On September 8, 2026 Astrazeneca reported positive high-level results from a planned interim analysis of the DeLLphi-305 Phase III trial showed IMFINZI (durvalumab) plus Amgen’s tarlatamab demonstrated a statistically significant and highly clinically meaningful improvement in overall survival (OS) versus IMFINZI alone as a 1st-line maintenance treatment. The trial included patients with extensive-stage small cell lung cancer (ES-SCLC) who had not progressed following standard induction treatment with IMFINZI in combination with platinum chemotherapy (investigator’s choice of carboplatin or cisplatin) and etoposide.

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IMFINZI plus tarlatamab also demonstrated a statistically significant and clinically meaningful improvement in the secondary endpoints of progression-free survival (PFS) and objective response rate.

In 2026, an estimated 195,000 people globally will be treated for ES-SCLC, a highly aggressive, fast-growing form of lung cancer characterized by rapid tumor progression and metastatic spread to organs such as the brain and liver.1,2 Immune checkpoint inhibitors such as IMFINZI have led to significant improvements in OS in ES-SCLC, establishing a 1st-line standard of care. However, many patients still experience disease progression due to the aggressive nature of the disease and median OS with the current standard of care is approximately one year.3

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "These results show that IMFINZI-based induction therapy followed by maintenance treatment with IMFINZI plus tarlatamab demonstrates an unprecedented improvement in overall survival for patients with this highly aggressive form of lung cancer. IMFINZI continues to reshape how lung cancer is treated, establishing new standards of care across multiple settings, and these new findings further underscore its role as the backbone immunotherapy of choice for small cell lung cancer."

Jacob Sands, MD, Associate Chief of the Lowe Center for Thoracic Oncology at Dana-Farber Cancer Institute, said: "Given the aggressive nature of small cell lung cancer, many patients quickly relapse on current therapy and never reach second-line treatment. These patients do not have time to wait, making substantial progress in the first-line setting critically important. In my career treating people with extensive-stage small cell lung cancer, these are among the most compelling survival results I have seen, indicating the potential to reshape the natural history of small cell lung cancer. DeLLphi-305 represents an unprecedented milestone and suggests we may be entering a new era where meaningfully longer survival is possible for more patients."

Overall, the safety and tolerability profile of IMFINZI plus tarlatamab was consistent with the known safety profiles of the individual treatments, with no new safety signals identified. These data will be presented at a forthcoming medical meeting and shared with global regulatory authorities.

IMFINZI is approved in the US, EU, Japan, China and many other countries around the world as the standard-of-care treatment for ES-SCLC and limited-stage SCLC (LS-SCLC) based on the CASPIAN and ADRIATIC Phase III trials, respectively.

IMPORTANT SAFETY INFORMATION

There are no contraindications for IMFINZI (durvalumab) or IMJUDO (tremelimumab-actl).

Severe and Fatal Immune-Mediated Adverse Reactions
Important immune-mediated adverse reactions listed under Warnings and Precautions may not include all possible severe and fatal immune-mediated reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. Immune-mediated adverse reactions can occur at any time after starting treatment or after discontinuation. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and before each dose. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue IMFINZI and IMJUDO depending on severity. See USPI Dosing and Administration for specific details. In general, if IMFINZI and IMJUDO requires interruption or discontinuation, administer systemic corticosteroid therapy (1 mg to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy.

Immune-Mediated Pneumonitis
IMFINZI and IMJUDO can cause immune-mediated pneumonitis, which may be fatal. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation.

IMFINZI as a Single Agent
In patients who did not receive recent prior radiation, the incidence of immune-mediated pneumonitis was 2.4% (34/1414), including fatal (<0.1%), and Grade 3-4 (0.4%) adverse reactions.
In patients who received recent prior radiation, the incidence of pneumonitis (including radiation pneumonitis) in patients with unresectable Stage III NSCLC following definitive chemoradiation within 42 days prior to initiation of IMFINZI in PACIFIC was 18.3% (87/475) in patients receiving IMFINZI and 12.8% (30/234) in patients receiving placebo. Of the patients who received IMFINZI (475), 1.1% were fatal and 2.7% were Grade 3 adverse reactions.
The incidence of pneumonitis (including radiation pneumonitis) in patients with LS-SCLC following chemoradiation within 42 days prior to initiation of IMFINZI in ADRIATIC was 14% (37/262) in patients receiving IMFINZI and 6% (16/265) in patients receiving placebo. Of the patients who received IMFINZI (262), 0.4% had a fatal adverse reaction and 2.7% had Grade 3 adverse reactions.
The frequency and severity of immune-mediated pneumonitis in patients who did not receive definitive chemoradiation prior to IMFINZI were similar in patients who received IMFINZI as a single agent or with ES-SCLC or BTC when given in combination with chemotherapy.
IMFINZI with IMJUDO
Immune‑mediated pneumonitis occurred in 1.3% (5/388) of patients receiving IMFINZI and IMJUDO, including fatal (0.3%) and Grade 3 (0.2%) adverse reactions.
IMFINZI with IMJUDO and Platinum-Based Chemotherapy
Immune-mediated pneumonitis occurred in 3.5% (21/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including fatal (0.5%), and Grade 3 (1%) adverse reactions.
Immune-Mediated Colitis
IMFINZI with IMJUDO and platinum-based chemotherapy can cause immune-mediated colitis, which may be fatal. IMFINZI and IMJUDO can cause immune-mediated colitis that is frequently associated with diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies.

IMFINZI as a Single Agent
Immune-mediated colitis occurred in 2% (37/1889) of patients receiving IMFINZI, including Grade 4 (<0.1%) and Grade 3 (0.4%) adverse reactions.
IMFINZI with IMJUDO
Immune‑mediated colitis or diarrhea occurred in 6% (23/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (3.6%) adverse reactions. Intestinal perforation has been observed in other studies of IMFINZI and IMJUDO.
IMFINZI with IMJUDO and Platinum-Based Chemotherapy
Immune-mediated colitis occurred in 6.5% (39/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy including fatal (0.2%) and Grade 3 (2.5%) adverse reactions. Intestinal perforation and large intestine perforation were reported in 0.1% of patients.
Immune-Mediated Hepatitis
IMFINZI and IMJUDO can cause immune-mediated hepatitis, which may be fatal.

IMFINZI as a Single Agent
Immune-mediated hepatitis occurred in 2.8% (52/1889) of patients receiving IMFINZI, including fatal (0.2%), Grade 4 (0.3%) and Grade 3 (1.4%) adverse reactions.
IMFINZI with IMJUDO
Immune‑mediated hepatitis occurred in 7.5% (29/388) of patients receiving IMFINZI and IMJUDO, including fatal (0.8%), Grade 4 (0.3%) and Grade 3 (4.1%) adverse reactions.
IMFINZI with IMJUDO and Platinum-Based Chemotherapy
Immune-mediated hepatitis occurred in 3.9% (23/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including fatal (0.3%), Grade 4 (0.5%), and Grade 3 (2%) adverse reactions.
Immune-Mediated Endocrinopathies

Adrenal Insufficiency: IMFINZI and IMJUDO can cause primary or secondary adrenal insufficiency. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated.
IMFINZI as a Single Agent
Immune-mediated adrenal insufficiency occurred in 0.5% (9/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.
IMFINZI with IMJUDO
Immune-mediated adrenal insufficiency occurred in 1.5% (6/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.3%) adverse reactions.
IMFINZI with IMJUDO and Platinum-Based Chemotherapy
Immune-mediated adrenal insufficiency occurred in 2.2% (13/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.8%) adverse reactions.
Hypophysitis: IMFINZI and IMJUDO can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field cuts. Hypophysitis can cause hypopituitarism. Initiate symptomatic treatment including hormone replacement as clinically indicated.
IMFINZI as a Single Agent
Grade 3 hypophysitis/hypopituitarism occurred in <0.1% (1/1889) of patients who received IMFINZI.
IMFINZI with IMJUDO
Immune-mediated hypophysitis/hypopituitarism occurred in 1% (4/388) of patients receiving IMFINZI and IMJUDO.
IMFINZI with IMJUDO and Platinum-Based Chemotherapy
Immune-mediated hypophysitis occurred in 1.3% (8/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.5%) adverse reactions.
Thyroid Disorders: IMFINZI and IMJUDO can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement therapy for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated.
IMFINZI as a Single Agent
Immune-mediated thyroiditis occurred in 0.5% (9/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.
Immune-mediated hyperthyroidism occurred in 2.1% (39/1889) of patients receiving IMFINZI.
Immune-mediated hypothyroidism occurred in 8.3% (156/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.
IMFINZI with IMJUDO
Immune-mediated thyroiditis occurred in 1.5% (6/388) of patients receiving IMFINZI and IMJUDO.
Immune-mediated hyperthyroidism occurred in 4.6% (18/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.3%) adverse reactions.
Immune-mediated hypothyroidism occurred in 11% (42/388) of patients receiving IMFINZI and IMJUDO.
IMFINZI with IMJUDO and Platinum-Based Chemotherapy
Immune-mediated thyroiditis occurred in 1.2% (7/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy.
Immune-mediated hyperthyroidism occurred in 5% (30/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.2%) adverse reactions.
Immune-mediated hypothyroidism occurred in 8.6% (51/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.5%) adverse reactions.
IMFINZI with Carboplatin and Paclitaxel
Immune-mediated hypothyroidism occurred in 14% (34/235) of patients receiving IMFINZI in combination with carboplatin and paclitaxel.
Type 1 Diabetes Mellitus, which can present with diabetic ketoacidosis: Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated.
IMFINZI as a Single Agent
Grade 3 immune-mediated Type 1 diabetes mellitus occurred in <0.1% (1/1889) of patients receiving IMFINZI.
IMFINZI with IMJUDO
Two patients (0.5%, 2/388) had events of hyperglycemia requiring insulin therapy that had not resolved at last follow-up.
IMFINZI with IMJUDO and Platinum-Based Chemotherapy
Immune-mediated Type 1 diabetes mellitus occurred in 0.5% (3/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy including Grade 3 (0.3%) adverse reactions.
Immune-Mediated Nephritis with Renal Dysfunction
IMFINZI and IMJUDO can cause immune-mediated nephritis.

IMFINZI as a Single Agent
Immune-mediated nephritis occurred in 0.5% (10/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.
IMFINZI with IMJUDO
Immune-mediated nephritis occurred in 1% (4/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.5%) adverse reactions.
IMFINZI with IMJUDO and Platinum-Based Chemotherapy
Immune-mediated nephritis occurred in 0.7% (4/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.2%) adverse reactions.
Immune-Mediated Dermatology Reactions
IMFINZI and IMJUDO can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson Syndrome (SJS), drug rash with eosinophilia and systemic symptoms (DRESS), and toxic epidermal necrolysis (TEN), has occurred with PD-1/L-1 and CTLA-4 blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes.

IMFINZI as a Single Agent
Immune-mediated rash or dermatitis occurred in 1.8% (34/1889) of patients receiving IMFINZI, including Grade 3 (0.4%) adverse reactions.
IMFINZI with IMJUDO
Immune-mediated rash or dermatitis occurred in 4.9% (19/388) of patients receiving IMFINZI and IMJUDO, including Grade 4 (0.3%) and Grade 3 (1.5%) adverse reactions.
IMFINZI with IMJUDO and Platinum-Based Chemotherapy
Immune-mediated rash or dermatitis occurred in 7.2% (43/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.3%) adverse reactions.
Immune-Mediated Pancreatitis
IMFINZI in combination with IMJUDO can cause immune-mediated pancreatitis. Immune-mediated pancreatitis occurred in 2.3% (9/388) of patients receiving IMFINZI and IMJUDO, including Grade 4 (0.3%) and Grade 3 (1.5%) adverse reactions.

Other Immune-Mediated Adverse Reactions
The following clinically significant, immune-mediated adverse reactions occurred at an incidence of less than 1% each in patients who received IMFINZI and IMJUDO or were reported with the use of other immune-checkpoint inhibitors.

Cardiac/vascular: Myocarditis, pericarditis, vasculitis.
Nervous system: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy.
Ocular: Uveitis, iritis, and other ocular inflammatory toxicities can occur. Some cases can be associated with retinal detachment. Various grades of visual impairment to include blindness can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss.
Gastrointestinal: Pancreatitis including increases in serum amylase and lipase levels, gastritis, duodenitis.
Musculoskeletal and connective tissue disorders: Myositis/polymyositis, rhabdomyolysis and associated sequelae including renal failure, arthritis, polymyalgia rheumatica.
Endocrine: Hypoparathyroidism.
Hematologic/Immune: Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenia, solid organ transplant rejection, other transplant (including corneal graft) rejection.
Other: Myocarditis-Myositis-Myasthenia Gravis (or Myasthenia-Like) Overlap Syndrome, reported as the co-occurrence of either two or all three adverse reactions
Infusion-Related Reactions
IMFINZI and IMJUDO can cause severe or life-threatening infusion-related reactions. Monitor for signs and symptoms of infusion-related reactions. Interrupt, slow the rate of, or permanently discontinue IMFINZI and IMJUDO based on the severity. See USPI Dosing and Administration for specific details. For Grade 1 or 2 infusion-related reactions, consider using pre-medications with subsequent doses.

IMFINZI as a Single Agent
Infusion-related reactions occurred in 2.2% (42/1889) of patients receiving IMFINZI, including Grade 3 (0.3%) adverse reactions.
IMFINZI with IMJUDO
Infusion-related reactions occurred in 2.6% (10/388) of patients receiving IMFINZI and IMJUDO.
IMFINZI with IMJUDO and Platinum-Based Chemotherapy
Infusion-related reactions occurred in 2.9% (17/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.3%) adverse reactions.
Complications of Allogeneic HSCT after IMFINZI
Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/L-1 blocking antibody. Transplant-related complications include hyperacute graft-versus-host disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between PD-1/L-1 blockade and allogeneic HSCT. Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with a PD-1/L-1 blocking antibody prior to or after an allogeneic HSCT.

Embryo-Fetal Toxicity
Based on their mechanism of action and data from animal studies, IMFINZI and IMJUDO can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. In females of reproductive potential, verify pregnancy status prior to initiating IMFINZI and IMJUDO and advise them to use effective contraception during treatment with IMFINZI and IMJUDO and for 3 months after the last dose of IMFINZI and IMJUDO.

Lactation
There is no information regarding the presence of IMFINZI and IMJUDO in human milk; however, because of the potential for serious adverse reactions in breastfed infants from IMFINZI and IMJUDO, advise women not to breastfeed during treatment and for 3 months after the last dose.

Adverse Reactions
Unresectable Stage III NSCLC

In patients with Stage III NSCLC in the PACIFIC study receiving IMFINZI (n=475), the most common adverse reactions (≥20%) were cough (40%), fatigue (34%), pneumonitis or radiation pneumonitis (34%), upper respiratory tract infections (26%), dyspnea (25%), and rash (23%). The most common Grade 3 or 4 adverse reactions (≥3%) were pneumonia (7%) and pneumonitis/radiation pneumonitis (3.4%).
In patients with Stage III NSCLC in the PACIFIC study receiving IMFINZI (n=475), discontinuation due to adverse reactions occurred in 15% of patients in the IMFINZI arm. Serious adverse reactions occurred in 29% of patients receiving IMFINZI. The most frequent serious adverse reactions (≥2%) were pneumonitis or radiation pneumonitis (7%) and pneumonia (6%). Fatal pneumonitis or radiation pneumonitis and fatal pneumonia occurred in <2% of patients and were similar across arms.
Resectable NSCLC

In patients with resectable NSCLC in the AEGEAN study, the most common adverse reactions (occurring in ≥20% of patients) were anemia, nausea, constipation, fatigue, musculoskeletal pain, and rash.
In patients with resectable NSCLC in the neoadjuvant phase of the AEGEAN study receiving IMFINZI in combination with platinum-containing chemotherapy (n=401), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 6.7% of patients. Serious adverse reactions occurred in 21% of patients. The most frequent (≥1%) serious adverse reactions were pneumonia (2.7%), anemia (1.5%), myelosuppression (1.5%), vomiting (1.2%), neutropenia (1%), and acute kidney injury (1%). Fatal adverse reactions occurred in 2% of patients, including death due to COVID-19 pneumonia (0.5%), sepsis (0.5%), myocarditis (0.2%), decreased appetite (0.2%), hemoptysis (0.2%), and death not otherwise specified (0.2%). Of the 401 IMFINZI-treated patients who received neoadjuvant treatment and 398 placebo-treated patients who received neoadjuvant treatment, 1.7% (n=7) and 1% (n=4), respectively, did not receive surgery due to adverse reactions.
In patients with resectable NSCLC in the adjuvant phase of the AEGEAN study receiving IMFINZI as a single agent (n=265), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 8% of patients. Serious adverse reactions occurred in 13% of patients. The most frequent serious adverse reactions reported in >1% of patients were pneumonia (1.9%), pneumonitis (1.1%), and COVID-19 (1.1%). Four fatal adverse reactions occurred during the adjuvant phase of the study, including COVID-19 pneumonia, pneumonia aspiration, interstitial lung disease and aortic aneurysm.
Metastatic NSCLC

In patients with mNSCLC in the POSEIDON study receiving IMFINZI and IMJUDO plus platinum-based chemotherapy (n=330), the most common adverse reactions (occurring in ≥20% of patients) were nausea (42%), fatigue (36%), musculoskeletal pain (29%), decreased appetite (28%), rash (27%), and diarrhea (22%).
In patients with mNSCLC in the POSEIDON study receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy (n=330), permanent discontinuation of IMFINZI or IMJUDO due to an adverse reaction occurred in 17% of patients. Serious adverse reactions occurred in 44% of patients, with the most frequent serious adverse reactions reported in at least 2% of patients being pneumonia (11%), anemia (5%), diarrhea (2.4%), thrombocytopenia (2.4%), pyrexia (2.4%), and febrile neutropenia (2.1%). Fatal adverse reactions occurred in a total of 4.2% of patients.
Limited-stage Small Cell Lung Cancer

In patients with limited-stage SCLC in the ADRIATIC study receiving IMFINZI (n=262), the most common adverse reactions occurring in ≥20% of patients receiving IMFINZI were pneumonitis or radiation pneumonitis (38%), and fatigue (21%). The most common Grade 3 or 4 adverse reactions (≥3%) were pneumonitis or radiation pneumonitis and pneumonia.
In patients with limited-stage SCLC in the ADRIATIC study receiving IMFINZI (n=262), IMFINZI was permanently discontinued due to adverse reactions in 16% of the patients receiving IMFINZI. Serious adverse reactions occurred in 30% of patients receiving IMFINZI. The most frequent serious adverse reactions reported in ≥1% of patients receiving IMFINZI were pneumonitis or radiation pneumonitis (12%), and pneumonia (5%). Fatal adverse reactions occurred in 2.7% of patients who received IMFINZI including pneumonia (1.5%), cardiac failure, encephalopathy and pneumonitis (0.4% each).
Extensive-stage Small Cell Lung Cancer

In patients with extensive-stage SCLC in the CASPIAN study receiving IMFINZI plus chemotherapy (n=265), the most common adverse reactions (≥20%) were nausea (34%), fatigue/asthenia (32%), and alopecia (31%). The most common Grade 3 or 4 adverse reaction (≥3%) was fatigue/asthenia (3.4%).
In patients with extensive-stage SCLC in the CASPIAN study receiving IMFINZI plus chemotherapy (n=265), IMFINZI was discontinued due to adverse reactions in 7% of the patients receiving IMFINZI plus chemotherapy. Serious adverse reactions occurred in 31% of patients receiving IMFINZI plus chemotherapy. The most frequent serious adverse reactions reported in at least 1% of patients were febrile neutropenia (4.5%), pneumonia (2.3%), anemia (1.9%), pancytopenia (1.5%), pneumonitis (1.1%), and COPD (1.1%). Fatal adverse reactions occurred in 4.9% of patients receiving IMFINZI plus chemotherapy.
Locally Advanced or Metastatic Biliary Tract Cancers (BTCs)

In patients with locally advanced or metastatic BTCs in the TOPAZ-1 study receiving IMFINZI (n=338), the most common adverse reactions (occurring in ≥20% of patients) were fatigue (42%), nausea (40%), constipation (32%), decreased appetite (26%), abdominal pain (24%), rash (23%), and pyrexia (20%).
In patients with locally advanced or metastatic BTCs in the TOPAZ-1 study receiving IMFINZI (n=338), discontinuation due to adverse reactions occurred in 6% of the patients receiving IMFINZI plus chemotherapy. Serious adverse reactions occurred in 47% of patients receiving IMFINZI plus chemotherapy. The most frequent serious adverse reactions reported in at least 2% of patients were cholangitis (7%), pyrexia (3.8%), anemia (3.6%), sepsis (3.3%), and acute kidney injury (2.4%). Fatal adverse reactions occurred in 3.6% of patients receiving IMFINZI plus chemotherapy. These include ischemic or hemorrhagic stroke (4 patients), sepsis (2 patients), and upper gastrointestinal hemorrhage (2 patients).
Unresectable Hepatocellular Carcinoma (HCC)

In patients with unresectable HCC in the HIMALAYA study receiving IMFINZI and IMJUDO (n=388), the most common adverse reactions (occurring in ≥20% of patients) were rash (32%), diarrhea (27%), fatigue (26%), pruritus (23%), musculoskeletal pain (22%), and abdominal pain (20%).
In patients with unresectable HCC in the HIMALAYA study receiving IMFINZI and IMJUDO (n=388), serious adverse reactions occurred in 41% of patients. Serious adverse reactions in >1% of patients included hemorrhage (6%), diarrhea (4%), sepsis (2.1%), pneumonia (2.1%), rash (1.5%), vomiting (1.3%), acute kidney injury (1.3%), and anemia (1.3%). Fatal adverse reactions occurred in 8% of patients who received IMFINZI and IMJUDO, including death (1%), hemorrhage intracranial (0.5%), cardiac arrest (0.5%), pneumonitis (0.5%), hepatic failure (0.5%), and immune-mediated hepatitis (0.5%). Permanent discontinuation of treatment regimen due to an adverse reaction occurred in 14% of patients.
Primary Advanced or Recurrent dMMR Endometrial Cancer

In patients with primary advanced or recurrent dMMR endometrial cancer in the DUO-E study receiving IMFINZI in combination with carboplatin and paclitaxel followed by IMFINZI as a single agent (n=44), the most common adverse reactions, including laboratory abnormalities (occurring in >20% of patients) were peripheral neuropathy (61%), musculoskeletal pain (59%), nausea (59%), alopecia (52%), fatigue (41%), abdominal pain (39%), constipation (39%), rash (39%), decreased magnesium (36%), increased ALT (32%), increased AST (30%), diarrhea (27%), vomiting (27%), cough (27%), decreased potassium (25%), dyspnea (25%), headache (23%), increased alkaline phosphatase (20%), and decreased appetite (18%). The most common Grade 3 or 4 adverse reactions (≥3%) were constipation (4.5%) and fatigue (4.5%).
In patients with primary advanced or recurrent dMMR endometrial cancer in the DUO-E study receiving IMFINZI in combination with carboplatin and paclitaxel followed by IMFINZI as a single agent (n=44), permanent discontinuation of IMFINZI due to adverse reactions occurred in 11% of patients. Serious adverse reactions occurred in 30% of patients who received IMFINZI with carboplatin and paclitaxel; the most common serious adverse reactions (≥4%) were constipation (4.5%) and rash (4.5%).
BCG-Naive, High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC)

In patients with BCG-naive, HR-NMIBC in the POTOMAC study receiving IMFINZI in combination with BCG, the most common (≥20%) adverse reactions, including laboratory abnormalities were increased glucose (43%), increased AST (43%), increased lipase (42%), increased ALT (42%), increased GGT (40%), urinary tract infection (40%), increased potassium (39%), dysuria (37%), decreased hemoglobin (35%), hematuria (33%), increased serum creatinine (30%), musculoskeletal pain (28%), decreased lymphocytes (27%), urinary frequency (26%), decreased sodium (23%), fatigue (21%), rash (20%), and pyrexia (20%).
In patients with BCG-naive, HR-NMIBC in the POTOMAC study receiving IMFINZI in combination with BCG, permanent discontinuation of IMFINZI due to adverse reactions occurred in 18% of patients. The adverse reactions which resulted in permanent discontinuation of IMFINZI (≥1%) were hepatitis (1.8%), acute kidney injury (1.2%), and diarrhea (1.2%). Serious adverse reactions occurred in 32% of patients. The most common (≥1%) serious adverse reactions were urinary tract infection (4.5%), COVID (1.8%), hepatitis (1.5%), dysuria (1.2%), and prostate cancer (1.2%). Fatal adverse reactions occurred in 2.4% of patients who received IMFINZI in combination with BCG, including congestive cardiac failure (0.6%), COVID (0.3%), cardiovascular disorder (0.3%), dementia with Lewy bodies (0.3%), and pancreatic cancer (0.3%).
Muscle-Invasive Bladder Cancer (MIBC)

In patients with MIBC, the most common adverse reactions, including laboratory abnormalities, in the overall study (occurring in ≥20% of patients) were decreased hemoglobin, decreased neutrophils, increased blood creatinine, decreased sodium, nausea, increased ALT, decreased calcium, decreased platelets, fatigue, increased potassium, decreased lymphocytes, increased AST, constipation, decreased magnesium, decreased appetite, increased alkaline phosphatase, rash, pyrexia, diarrhea, vomiting and abdominal pain.
In patients with MIBC in the neoadjuvant phase of the NIAGARA study receiving IMFINZI in combination with gemcitabine and cisplatin (n=530), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 9% of patients. Serious adverse reactions occurred in 24% of patients; the most frequent (≥1%) serious adverse reactions were pulmonary embolism (1.9%), febrile neutropenia (1.5%), acute kidney injury (1.3%), thrombocytopenia (1.3%), urinary tract infection (1.3%), and pneumonia (1.3%). Fatal adverse reactions occurred in 1.1% of patients including sepsis, myocardial infarction, and pulmonary embolism (0.2% each). One fatal adverse reaction of pneumonia was reported in 1 (0.2%) patient in the post-surgery phase before adjuvant treatment started. Of the 530 patients in the IMFINZI treatment arm and 526 patients in the chemotherapy treatment arm who received neoadjuvant treatment, 1 (0.2%) patient in each treatment arm did not receive surgery due to adverse reactions. The adverse reaction that led to cancellation of surgery in the IMFINZI treatment arm was interstitial lung disease.
In patients with MIBC in the adjuvant phase of the NIAGARA study receiving IMFINZI as a single agent (n=383), permanent discontinuation of adjuvant IMFINZI due to an adverse reaction occurred in 5% of patients. Serious adverse reactions occurred in 26% of patients. The most frequent serious adverse reactions (occurring in ≥1% of patients) were urinary tract infection (7%), acute kidney injury (3.7%), hydronephrosis (2.1%), pyelonephritis (2.1%), urosepsis (1.8%) and sepsis (1.6%). Fatal adverse reactions occurred in 1.8% of patients, including COVID-19, severe acute respiratory syndrome, cardiopulmonary failure, gastrointestinal hemorrhage, and chronic hepatic failure (0.3% each).
Resectable Gastric Cancer/Gastroesophageal Junction Adenocarcinoma (GC/GEJC)

In patients with resectable GC/GEJC, the most common adverse reactions in the overall study (occurring in ≥20% of patients) were diarrhea, nausea, peripheral neuropathy, fatigue, alopecia, decreased appetite, rash, abdominal pain, vomiting, musculoskeletal pain, pyrexia, and stomatitis.
In patients with resectable GC/GEJC in the neoadjuvant phase of the MATTERHORN study receiving IMFINZI in combination with FLOT chemotherapy (n=475), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 2.5% of patients. Serious adverse reactions occurred in 21% of patients; the most frequent (≥2%) serious adverse reaction was diarrhea (2.5%). Deaths occurred in 1.9% of patients; deaths of ≥2 patients included septic shock (0.6%) and acute coronary syndrome (0.4%). Of the 475 patients in the IMFINZI + FLOT chemotherapy treatment arm and 469 patients in the placebo + FLOT chemotherapy treatment arm who received neoadjuvant treatment, 0.6% and 0.4% of patients, respectively, did not receive surgery due to adverse reactions, and 2.3% and 2.6% of patients, respectively, had a delay in surgery due to ARs.
In patients with resectable GC/GEJC in the adjuvant phase of the MATTERHORN study receiving IMFINZI in combination with FLOT chemotherapy (n=365), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 7% of patients. Serious adverse reactions occurred in 29% of patients; the most frequent (≥2%) serious adverse reaction was pneumonia (2.5%). Deaths occurred in 2.2% of patients; deaths of ≥2 patients included gastrointestinal perforation (0.5%) and COVID-19 (0.5%).
In patients with resectable GC/GEJC in the adjuvant phase of the MATTERHORN study receiving IMFINZI alone (n=345), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 6% of patients. Serious adverse reactions occurred in 14% of patients. Deaths occurred in 1.7% of patients; deaths of ≥2 patients included gastrointestinal perforation (0.6%) and COVID-19 (0.6%).
The safety and effectiveness of IMFINZI and IMJUDO have not been established in pediatric patients.

Indications:

IMFINZI, as a single agent, is indicated for the treatment of adult patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (cCRT).

IMFINZI in combination with platinum-containing chemotherapy as neoadjuvant treatment, followed by IMFINZI continued as a single agent as adjuvant treatment after surgery, is indicated for the treatment of adult patients with resectable (tumors ≥4 cm and/or node positive) NSCLC and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.

IMFINZI, in combination with IMJUDO and platinum-based chemotherapy, is indicated for the treatment of adult patients with metastatic NSCLC with no sensitizing EGFR mutations or ALK genomic tumor aberrations.

IMFINZI, as a single agent, is indicated for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (cCRT).

IMFINZI, in combination with etoposide and either carboplatin or cisplatin, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).

IMFINZI, in combination with gemcitabine and cisplatin, is indicated for the treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC).

IMFINZI in combination with IMJUDO is indicated for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC).

IMFINZI in combination with carboplatin and paclitaxel followed by IMFINZI as a single agent is indicated for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR) as determined by an FDA-authorized test.

IMFINZI in combination with Bacillus Calmette-Guérin (BCG) is indicated for the treatment of adult patients with BCG-naive, high-risk non-muscle-invasive bladder cancer (HR-NMIBC).

IMFINZI in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent IMFINZI as adjuvant treatment following radical cystectomy, is indicated for the treatment of adult patients with muscle-invasive bladder cancer (MIBC).

IMFINZI in combination with fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) as neoadjuvant and adjuvant treatment, followed by single agent IMFINZI, is indicated for the treatment of adult patients with resectable gastric or gastroesophageal junction adenocarcinoma (GC/GEJC).

Please see Full Prescribing Information including Medication Guide for IMFINZI and IMJUDO.

Notes

Small cell lung cancer
Lung cancer is the leading cause of cancer death globally, accounting for almost one in five (19%) cancer deaths.4,5 Lung cancer is broadly split into non-small cell lung cancer (NSCLC) and SCLC, with about 15% classified as SCLC.6 About two-thirds of SCLC patients are diagnosed with ES-SCLC, in which the cancer has spread widely through the lung or to other parts of the body.3 While survival rates have improved in recent years following the introduction of immune checkpoint inhibitors, prognosis is still poor, with only 18.1% of LS-SCLC patients and 3.6% of ES-SCLC patients alive five years after diagnosis.2 ​

DeLLphi-305
The DeLLphi-305 trial is sponsored by Amgen, with partial funding and IMFINZI provided by AstraZeneca. It is a global Phase III, randomized, open-label clinical trial evaluating the efficacy and safety of IMFINZI in combination with tarlatamab compared to IMFINZI alone as 1st-line maintenance treatment for patients with ES-SCLC who have not progressed following induction treatment with IMFINZI in combination with platinum chemotherapy and etoposide.

Tarlatamab is a first-in-class targeted immunotherapy that binds to both DLL3 on tumor cells and CD3 on T cells, thereby activating T cells to kill DLL3-expressing SCLC cells. DLL3 is a protein that is expressed on the surface of SCLC cells in ~85-96% of patients with SCLC, but is minimally expressed on healthy cells.

In the trial, 563 patients who completed IMFINZI-based induction treatment were randomized 1:1 to receive either IMFINZI in combination with tarlatamab or IMFINZI alone until progression or unacceptable toxicity. Following tarlatamab infusion on Cycle 1 Day 1 and Cycle 1 Day 8, patients were monitored in a healthcare setting for 1 to 2 hours (6 to 8 hours in certain regions including Europe). The trial included patients with both treated and untreated asymptomatic brain metastases at baseline.

The primary endpoint is OS for IMFINZI plus tarlatamab versus IMFINZI alone. PFS is a key secondary endpoint.

IMFINZI (durvalumab)
IMFINZI (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumor’s immune-evading tactics and releasing the inhibition of immune responses.

In addition to its indications in SCLC, IMFINZI is the global standard of care based on OS in the curative-intent setting of unresectable, Stage III NSCLC in patients whose disease has not progressed after chemoradiotherapy (CRT). Additionally, IMFINZI is approved as a perioperative treatment in combination with neoadjuvant chemotherapy in resectable NSCLC, and in combination with a short course of IMJUDO (tremelimumab-actl) and chemotherapy for the treatment of metastatic NSCLC.

IMFINZI is also approved in combination with chemotherapy in locally advanced or metastatic biliary tract cancer and in combination with IMJUDO in unresectable hepatocellular carcinoma (HCC). It is also approved as a monotherapy in unresectable HCC in Japan, China and the EU, and in resectable, early-stage and locally advanced gastric and gastroesophageal junction cancers in the US and the EU. Additionally, in April 2026, IMFINZI in combination with IMJUDO, lenvatinib and transarterial chemoembolization (TACE) demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of PFS versus TACE alone for patients with unresectable HCC eligible for embolization in the EMERALD-3 Phase III trial.

Perioperative IMFINZI in combination with neoadjuvant chemotherapy is approved for cisplatin-eligible muscle-invasive bladder cancer (MIBC). IMFINZI in combination with Bacillus Calmette-Guérin (BCG) induction and maintenance therapy is approved in the US and other countries for patients with BCG-naïve, high-risk non-muscle-invasive bladder cancer. In May 2026, positive high-level results from the VOLGA Phase III trial showed that perioperative treatment with IMFINZI in combination with neoadjuvant enfortumab vedotin (EV) demonstrated statistically significant and clinically meaningful improvements in event-free survival (EFS) and OS in patients with MIBC who were ineligible for or had declined cisplatin-based chemotherapy. In addition, perioperative IMFINZI plus IMJUDO in combination with neoadjuvant EV demonstrated a statistically significant and clinically meaningful improvement in EFS and a favorable trend for OS; however, the OS data were not statistically significant at this planned interim analysis and will be formally reassessed at a subsequent analysis. In July 2026, positive high-level results from the NILE Phase III trial showed IMFINZI plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in OS versus chemotherapy as 1st-line treatment for patients with PD-L1 high unresectable, locally advanced or metastatic urothelial cancer.

IMFINZI in combination with chemotherapy followed by IMFINZI monotherapy is approved as a 1st-line treatment for primary advanced or recurrent endometrial cancer (mismatch repair deficient disease only in US, EU and China). IMFINZI in combination with chemotherapy followed by olaparib and IMFINZI is approved for patients with mismatch repair proficient advanced or recurrent endometrial cancer in EU and Japan.

Since the first approval in May 2017, more than 470,000 patients have been treated with IMFINZI. As part of a broad development program, IMFINZI is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with NSCLC, bladder cancer, breast cancer, ovarian cancer and several gastrointestinal cancers.

(Press release, AstraZeneca, SEP 8, 2026, View Source [SID1234670647])

On September 8, 2026 PeproMene Bio, Inc. reported the publication in The Lancet, one of the world’s leading medical journals, of results from its Phase 1 clinical trial evaluating PMB-CT01, the company’s first-in-class BAFF-R-targeted CAR T-cell therapy, in patients with relapsed or refractory B-cell non-Hodgkin lymphoma.

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The publication reports durable complete clinical responses, together with a more favorable safety profile compared with approved CAR T-cell therapies. Seven of nine treated patients (80%) achieved a complete response (CR), including four of six patients who had progressed after conventional CD19-directed CAR T-cell therapy ("CAR after CAR"). All complete responses remained ongoing at the time of data cutoff, with no relapses observed and the longest ongoing complete response reaching 35 months, suggesting the likelihood of cure.

PMB-CT01 was remarkably safe, as all cytokine release syndrome (CRS) events and the two reported immune effector cell-associated neurotoxicity syndrome (ICANS) events were limited to Grade 1.

Based on these promising results, the Phase 1 trial has expanded from a single clinical trial site at City of Hope, a cancer research and treatment organization, to multiple additional medical centers across the United States. The publication also reports that the first patient treated in the expansion phase—who had triple-hit high-grade B-cell lymphoma following progression after CD19-directed CAR T-cell therapy—also achieved a complete response at the first disease assessment.

"Publishing these peer-reviewed data in The Lancet represents a significant recognition of this novel therapy," said Larry W. Kwak, M.D., Ph.D., scientific founder of PeproMene Bio. "With the lack of any relapses, we believe PMB-CT01 is a paradigm-shifting CAR T-cell option for blood cancers which were previously thought to be incurable. Its elite safety may also enable outpatient administration—improving access for underserved patients—while also opening doors for treating autoimmune diseases where B-cell depletion is already proven."

"These early results are encouraging, particularly for patients whose disease progressed after CD19 or CD20-directed T-cell therapy," said Stephen Forman, M.D., paper co-author and director of the Hematologic Malignancies Institute at City of Hope. "City of Hope will continue to support the trial as the coordinating center and manufacturing site in addition to patient enrollment."

In December 2024, the Institute for Follicular Lymphoma Innovation (IFLI) committed up to $11 million to support the clinical development of PMB-CT01 in patients with relapsed or refractory follicular lymphoma. "For patients whose lymphoma returns after CD19-directed CAR T-cell therapy, a new target can mean a new chance. IFLI is proud to support PeproMene Bio in advancing BAFF-R CAR T-cell therapy and encouraged by these early, durable responses," said Mehrdad Mobasher, M.D., M.P.H., Executive Partner at the Institute for Follicular Lymphoma Innovation.

Publication Details

Title: BAFF-R CAR T-cell therapy for relapsed or refractory B-cell lymphomas

Journal: The Lancet (Research Letter)

DOI: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(26)01329-2/fulltext

About PMB-CT01

PMB-CT01 is a first-in-class B-cell activating factor receptor (BAFF-R)-targeted autologous CAR T-cell therapy being evaluated in ongoing Phase 1 trials for relapsed/refractory B-NHL and relapsed/refractory B-ALL. BAFF-R is expressed almost exclusively on B cells and is essential for B-cell survival, reducing the likelihood of antigen-loss escape. PeproMene Bio has licensed intellectual property relating to PMB-CT01 from City of Hope.

(Press release, PeproMene Bio, SEP 8, 2026, View Source [SID1234670646])

On September 8, 2026 Inhibrx Biosciences, Inc. (Nasdaq: INBX) ("Inhibrx" or the "Company"), a clinical-stage biopharmaceutical company focused on developing a broad pipeline of novel biologic therapeutic candidates, reported the primary endpoint results from the randomized and controlled Phase 2 portion of the HexAgon study, which is evaluating the safety and efficacy of INBRX-106, a hexavalent OX40 agonist, in combination with pembrolizumab (the combination arm) versus pembrolizumab monotherapy (the control arm) in first-line patients with treatment-naïve, PD-L1 positive (CPS ≥ 20) metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC). Baseline prognostic factors were largely balanced between the two arms, and the study is being conducted at more than 80 sites in the United States, Europe and Asia. The Phase 2 portion of the HexAgon study included a total of 68 randomized patients, 63 of whom were evaluable for the primary endpoint analysis, including 29 patients in the combination arm (10 of which were HPV+) and 34 patients in the control arm (nine of which were HPV+).

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The primary endpoint analysis, which had a data cutoff of August 19, 2026, demonstrated a confirmed objective response rate (cORR) of 48.3% for INBRX-106 plus pembrolizumab compared with 26.5% for pembrolizumab alone. Four patients (13.8%) in the combination arm achieved a complete response compared with no complete responses in the control arm. Median progression-free survival (PFS) continues to mature. As of the data cutoff, median PFS was 9.6 months for INBRX-106 plus pembrolizumab compared with 4.9 months for pembrolizumab alone, with six-month PFS rates of 72.4% and 42.8%, respectively.

The efficacy signal was particularly pronounced in patients with HPV+ disease, where the combination arm demonstrated an 80.0% cORR compared with 33.3% for pembrolizumab alone. Notably, 30.0% of the HPV+ patients treated in the combination arm achieved a complete response, compared with no complete responses in the control arm. The durability of the benefit was also particularly striking, with 90.0% of patients receiving INBRX-106 plus pembrolizumab remaining progression-free at six months compared with 33.0% who were receiving pembrolizumab alone. As of the data cutoff, median PFS in the combination arm in patients with HPV+ disease had not yet been reached compared with 4.6 months for pembrolizumab alone.

The combination of INBRX-106 and pembrolizumab was generally manageable. The most common treatment-related adverse events were rash, fatigue, and diarrhea, which were predominantly low grade.

"What is most exciting to us is the depth and durability of the responses we are seeing with INBRX-106, particularly in HPV+ disease," said Mark Lappe, co-founder and Chief Executive Officer of Inhibrx. "These results strengthen our conviction in OX40-mediated T-cell costimulation and give us a strong rationale to expand the program, not only into HPV+ disease, but also to explore the potential of INBRX-106 in other highly immunogenic tumors and in combination with cancer vaccines."

Based on these results, Inhibrx plans to expand the randomized Phase 2 portion of the HexAgon trial by approximately 50 additional HPV+ Oropharyngeal Squamous Cell Carcinoma (OPSCC) patients (CPS ≥ 1), to support a potential accelerated regulatory pathway. Following the Phase 2 expansion, the Company plans to align with the FDA on this framework and initiate the Phase 3 portion of the HexAgon trial, which is intended to serve as the confirmatory study. These results also position OX40 agonism as a promising treatment approach beyond recurrent/metastatic disease, with potential to extend durable, T-cell driven antitumor activity into earlier-stage HPV+ OPSCC.

Beyond HNSCC, Inhibrx is evaluating the potential of INBRX-106 in other highly immunogenic tumor types. The Company is currently conducting a Phase 1/2 study of INBRX-106 in the perioperative setting of non-small cell lung cancer (NSCLC), with initial results targeted by mid-2027. This readout is expected to provide important clinical insights to inform future development, demonstrating the potential for INBRX-106 to extend well beyond head and neck cancer into not only perioperative lung cancer, but broader solid tumor indications.

The Company also plans to explore the potential of INBRX-106 in combination with therapeutic cancer vaccines. The clinical activity and T-cell responses observed with INBRX-106 in HPV+ disease demonstrate its ability to amplify antigen-driven T-cell responses, providing strong scientific justification for cancer vaccine combination strategies.

The Company will host a live webcast presentation today, September 8, 2026, at 5:00 a.m. Pacific Time to further discuss the results. The webcast will also include a slide presentation of the data, which is also incorporated into the Company’s investor deck accessible at View Source

About the Conference Call

Investors may join via the web: View Source or may listen to the call by dialing (1-888-880-3330). Please refer to Inhibrx Biosciences, Inc. or the conference ID 6981384 when calling in. The webcast will also include a slide presentation of the data, which is also incorporated into the Company’s investor deck accessible at View Source Following the webcast, the presentation may be accessed through a link on the "Events and Presentations" section of Inhibrx’s website. The webcast will be available for 60 days following the event. Inhibrx will also update its corporate presentation within the "Investors" section of its website at www.inhibrx.com.

About INBRX-106

INBRX-106 is a hexavalent agonist targeting OX40 (CD134), a costimulatory receptor on T-cells. Utilizing Inhibrx’s proprietary single-domain antibody (sdAb) platform, INBRX-106 is designed to achieve the high-order receptor clustering necessary for robust T-cell activation and survival, a feat that has eluded traditional bivalent antibody approaches.

(Press release, Inhibrx, SEP 8, 2026, View Source [SID1234670645])

On September 8, 2026 Amgen (NASDAQ: AMGN) reported landmark results from the Phase 3 DeLLphi-305 study, which met its primary endpoint at a pre-specified interim analysis, demonstrating a statistically significant and clinically meaningful improvement in overall survival with IMDELLTRA (tarlatamab-dlle) in combination with AstraZeneca’s Imfinzi (durvalumab) compared to durvalumab alone. This study tested IMDELLTRA as a first-line maintenance treatment for people with extensive stage small cell lung cancer (ES-SCLC) whose disease had not progressed following initial treatment with durvalumab, platinum-based chemotherapy and etoposide. The study also demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) and objective response rate (ORR) among patients treated with IMDELLTRA in combination with durvalumab.

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Overall, the safety profile of IMDELLTRA in combination with durvalumab was consistent with the known safety profiles of the individual medicines. No new or unexpected safety signals were identified in DeLLphi-305. The study design included monitoring in a healthcare setting for 1 to 2 hours (6 to 8 hours in certain regions including Europe) following IMDELLTRA infusion on Cycle 1 Day 1 and Cycle 1 Day 8.

"IMDELLTRA has already revolutionized the standard of survival for patients with extensive stage small cell lung cancer whose disease progressed on or after prior treatment. These landmark results from DeLLphi-305 suggest IMDELLTRA will further revolutionize the standard for survival earlier in the treatment journey and meaningfully shift the treatment paradigm for people facing this devastating disease," said Jay Bradner, M.D., executive vice president, Research and Development, Artificial Intelligence and Data at Amgen. "Despite clinical advances, extensive stage small cell lung cancer remains one of the most aggressive and difficult-to-treat cancers, and substantial improvements in survival are rare, underscoring the importance of these findings."

This marks the first Phase 3 study including a Bispecific T-cell Engager (BiTE) therapy to demonstrate an overall survival benefit in the first-line maintenance setting for ES-SCLC.

"Given the aggressive nature of small cell lung cancer, many patients quickly relapse on current therapy and never reach second-line treatment. These patients do not have time to wait, making substantial progress in the first-line setting critically important," said Jacob Sands, MD, Associate Chief of the Lowe Center for Thoracic Oncology at Dana-Farber Cancer Institute. "In my career treating people with extensive stage small cell lung cancer, these are among the most compelling survival results I have seen, indicating the potential to reshape the natural history of small cell lung cancer. DeLLphi-305 represents an unprecedented milestone and suggests we may be entering a new era where meaningfully longer survival is possible for more patients."

Following the U.S. Food and Drug Administration (FDA) approval of IMDELLTRA for adults with ES-SCLC whose disease has progressed on or after platinum-based chemotherapy, the robust global DeLLphi clinical trial program has continued to evaluate its potential across earlier stages of disease and lines of treatment, both as a monotherapy and in combination regimens. Building on the DeLLphi-303 trial, which showed very encouraging efficacy and tolerability results for IMDELLTRA in combination with anti-PD-L1 checkpoint inhibitors in the treatment of first-line ES-SCLC, DeLLphi-305 was designed to evaluate IMDELLTRA earlier in the course of disease, where more patients with SCLC may have the opportunity to benefit.

SCLC is one of the most aggressive forms of lung cancer, accounting for approximately 13-15% of the more than 2.6 million lung cancer cases diagnosed worldwide each year.1-3 Despite advances in the treatment of ES-SCLC, outcomes remain poor, with a median survival of approximately one year from the start of first-line maintenance treatment and only about 40% of patients receiving second-line therapy.4-7

Amgen plans to present detailed data from DeLLphi-305 at an upcoming international medical congress and share it with regulatory authorities.

About the Phase 3 DeLLphi-305 Study
The DeLLphi-305 trial is sponsored by Amgen, with partial funding and durvalumab provided by AstraZeneca. It is a global Phase 3, randomized, open-label clinical trial evaluating the efficacy and safety of IMDELLTRA in combination with durvalumab compared to durvalumab alone as first-line maintenance treatment for patients with ES-SCLC who had not progressed following treatment with durvalumab, platinum-based chemotherapy and etoposide. Five hundred and sixty-three patients who completed initial treatment with durvalumab, platinum-based chemotherapy and etoposide were randomized 1:1 to receive either IMDELLTRA in combination with durvalumab or durvalumab alone until progression or unacceptable toxicity. Following IMDELLTRA infusion on Cycle 1 Day 1 and Cycle 1 Day 8, patients were monitored in a healthcare setting for 1 to 2 hours (6 to 8 hours in certain regions including Europe). The trial included patients with both treated and untreated asymptomatic brain metastases at baseline. The primary outcome measure of the trial is OS. Secondary endpoints include progression-free survival (PFS) and objective response rate (ORR).8

About Tarlatamab Clinical Trials
Tarlatamab is being investigated in multiple studies including DeLLphi-303, a Phase 1b study investigating tarlatamab in combination with standard-of-care (SOC) therapies in first-line ES-SCLC; DeLLphi-304, a randomized Phase 3 study comparing tarlatamab monotherapy with SOC chemotherapy in second-line treatment of SCLC; DeLLphi-305, a randomized Phase 3 study comparing tarlatamab in combination with durvalumab vs. durvalumab alone as first-line maintenance treatment in ES-SCLC; DeLLphi-306, a randomized placebo-controlled Phase 3 study of tarlatamab following concurrent chemoradiotherapy in limited-stage SCLC; DeLLphi-308, a Phase 1b study evaluating subcutaneous tarlatamab in second-line or later ES-SCLC; DeLLphi-309, a Phase 2 study evaluating alternative intravenous dosing regimens with tarlatamab in second-line ES-SCLC; DeLLphi-310, a Phase 1b study of tarlatamab in combination with YL201 with or without durvalumab in patients with ES-SCLC; DeLLphi-311, a Phase 1b study of tarlatamab in combination with etakafusp alfa (AB248), a novel CD8+ T-cell selective interleukin-2 (IL-2), in patients with ES-SCLC; DeLLphi-312, a randomized Phase 3 study evaluating tarlatamab in combination with durvalumab, carboplatin and etoposide as an induction and maintenance therapy in first-line treatment of ES-SCLC; DeLLphi-313, a Phase 1b study of tarlatamab in combination with zocilurtatug pelitecan, a DLL3 targeting antibody drug conjugate, with and without durvalumab in patients with ES-SCLC, and DeLLphi-315, a Phase 3 study of subcutaneous tarlatamab in patients with second-line ES-SCLC.9

For more information, please visit www.tarlatamabclinicaltrials.com.

About IMDELLTRA (tarlatamab-dlle)
IMDELLTRA is a first-in-class targeted immunotherapy engineered by Amgen researchers to bind to both DLL3 on tumor cells and CD3 on T cells, thereby activating T cells to kill DLL3-expressing SCLC cells. This results in the formation of a cytolytic synapse with lysis of the cancer cell.10,11 DLL3 is a protein that is expressed on the surface of SCLC cells in ~85-96% of patients with SCLC, but is minimally expressed on healthy cells, making it an exciting target.12,13

U.S. INDICATION
IMDELLTRA (tarlatamab-dlle) is indicated for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.

IMDELLTRA IMPORTANT SAFETY INFORMATION

WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME

Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving IMDELLTRA. Initiate treatment with IMDELLTRA using the step-up dosing schedule to reduce the incidence and severity of CRS. Withhold IMDELLTRA until CRS resolves or permanently discontinue based on severity.

Neurologic toxicity and immune effector cell-associated neurotoxicity syndrome (ICANS), including life-threatening or fatal reactions, can occur in patients receiving IMDELLTRA. Monitor patients for signs and symptoms of neurologic toxicity, including ICANS, during treatment and treat promptly. Withhold IMDELLTRA until ICANS resolves or permanently discontinue based on severity.
WARNINGS AND PRECAUTIONS

Cytokine Release Syndrome (CRS): IMDELLTRA can cause CRS including life-threatening or fatal reactions. In the pooled safety population, CRS occurred in 57% (268/473) of patients who received IMDELLTRA, including 39% Grade 1, 15% Grade 2, 1.7% Grade 3 and 0.2% Grade 4. Recurrent CRS occurred in 24% of IMDELLTRA-treated patients including 20% Grade 1 and 3.4% Grade 2; one patient experienced recurrent Grade 3.

Among the 268 patients who experienced CRS, 73% had CRS after the first dose, 60% had CRS after the second dose, and 15% had CRS following the third or later dose. Following the Cycle 1 Day 1, Day 8, Day 15 infusions, 24%, 8%, and 1% of patients experienced Grade ≥ 2 CRS, respectively. From Cycle 2 onwards, 1.5% of patients experienced Grade ≥ 2 CRS. Of the patients who experienced CRS, 31% received steroids and 10% required tocilizumab. The median time to onset of all grade CRS from most recent dose of IMDELLTRA was 16 hours (range: start of infusion to 15 days). The median time to onset of Grade ≥ 2 CRS from most recent dose of IMDELLTRA was 15 hours (range: start of infusion to 15 days).

Clinical signs and symptoms of CRS included pyrexia, hypotension, fatigue, tachycardia, headache, hypoxia, nausea, and vomiting. Potentially life-threatening complications of CRS may include cardiac dysfunction, acute respiratory distress syndrome, neurologic toxicity, renal and/or hepatic failure, and disseminated intravascular coagulation (DIC).

Administer IMDELLTRA following the recommended step-up dosing and administer concomitant medications before and after Cycle 1 Day 1 and Cycle 1 Day 8 IMDELLTRA infusions as described in Table 3 of the Prescribing Information (PI) to reduce the risk of CRS. Administer IMDELLTRA in an appropriate healthcare facility equipped to monitor and manage CRS. Ensure patients are well hydrated prior to administration of IMDELLTRA.

Closely monitor patients for signs and symptoms of CRS during treatment with IMDELLTRA. At the first sign of CRS, immediately discontinue IMDELLTRA infusion, evaluate the patient for hospitalization and institute supportive care based on severity. Withhold or permanently discontinue IMDELLTRA based on severity. Counsel patients and caregivers to seek medical attention should signs or symptoms of CRS occur.

Neurologic Toxicity, Including ICANS: IMDELLTRA can cause life-threatening or fatal neurologic toxicity, including ICANS. In the pooled safety population, neurologic toxicity occurred in 65% of patients who received IMDELLTRA, with Grade 3 or higher events in 7% of patients including fatal events in 0.2%. The most frequent neurologic toxicities were dysgeusia (34%), headache (17%), peripheral neuropathy (9%), dizziness (9%), and insomnia (8%). The incidence of signs and symptoms consistent with ICANS was 10% in IMDELLTRA-treated patients including events with the preferred terms: ICANS (4.7%), muscular weakness (3.2%), cognitive disorder (0.6%), aphasia (0.6%), depressed level of consciousness (0.4%), seizures (0.4%), encephalopathy (0.4%), and leukoencephalopathy (0.2%). There was one fatal reaction of ICANS. Recurrent ICANS occurred in 1.5% of patients. Of the patients who experienced ICANS, most experienced the event following Cycle 1 Day 1 (2.5%) and Cycle 1 Day 8 (3.6%). Following Day 1, Day 8, and Day 15 infusions, 1.3%, 1.3% and 0.4% of patients experienced Grade ≥ 2 ICANS, respectively. ICANS can occur several weeks following administration of IMDELLTRA. The median time to onset of ICANS from the first dose of IMDELLTRA was 16 days (range: 1 to 862 days). The median time to resolution of ICANS was 4 days (range: 1 to 40 days).

The onset of ICANS can be concurrent with CRS, following resolution of CRS, or in the absence of CRS. Clinical signs and symptoms of ICANS may include but are not limited to confusional state, depressed level of consciousness, disorientation, somnolence, lethargy, and bradyphrenia.

Patients receiving IMDELLTRA are at risk of neurologic adverse reactions and ICANS resulting in depressed level of consciousness. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, until neurologic symptoms resolve.

Closely monitor patients for signs and symptoms of neurologic toxicity and ICANS during treatment with IMDELLTRA. At the first sign of ICANS, immediately discontinue the infusion, evaluate the patient and provide supportive therapy based on severity. Withhold IMDELLTRA or permanently discontinue based on severity.

Cytopenias: IMDELLTRA can cause cytopenias including neutropenia, thrombocytopenia, and anemia. In the pooled safety population, based on laboratory data, decreased neutrophils occurred in 16% of patients, including 9% Grade 3 or 4. The median time to onset for Grade 3 or 4 decreased neutrophil count was 41 days (range: 2 to 306 days). Decreased platelets occurred in 30% including 2.2% Grade 3 or 4. The median time to onset for Grade 3 or 4 decreased platelets was 67 days (range: 3 to 420 days). Decreased hemoglobin occurred in 56% of patients, including 4.7% Grade 3 or 4. Febrile neutropenia was reported as an adverse event in 1.5% of patients treated with IMDELLTRA.

Monitor patients for signs and symptoms of cytopenias. Perform complete blood counts prior to treatment with all doses of IMDELLTRA, up through Cycle 5 Day 15 and then prior to administration on Day 1 of each cycle starting with Cycle 6. Based on the severity of cytopenias, temporarily withhold, or permanently discontinue IMDELLTRA.

Infections: IMDELLTRA can cause serious infections, including life-threatening and fatal infections.

In the pooled safety population, infections, including opportunistic infections, occurred in 43% of patients who received IMDELLTRA, including 14% Grade 3 or 4. The most frequent infections were pneumonia (11%), urinary tract infection (9%), COVID-19 (6%), upper respiratory tract infection (4.7%), respiratory tract infection (4%), candida infection (2.1%), oral candidiasis (2.1%), and nasopharyngitis (2.1%).

Monitor patients for signs and symptoms of infection prior to and during treatment with IMDELLTRA and treat as clinically indicated. Withhold or permanently discontinue IMDELLTRA based on severity.

Hepatotoxicity: IMDELLTRA can cause hepatotoxicity. In the pooled safety population, based on laboratory data, elevated ALT occurred in 39% of patients who received IMDELLTRA, including 2.5% with Grade 3 or 4 ALT. Elevated AST occurred in 43% of patients, including 3.2% Grade 3 or 4. Elevated bilirubin also occurred in 16% of patients, including 1.3% Grade 3 or 4. Liver enzyme elevation can occur with or without concurrent CRS.

Monitor liver enzymes and bilirubin prior to treatment with IMDELLTRA, and as clinically indicated. Withhold IMDELLTRA or permanently discontinue based on severity.

Hypersensitivity: IMDELLTRA can cause severe hypersensitivity reactions. Clinical signs and symptoms of hypersensitivity may include, but are not limited to, rash and bronchospasm. Monitor patients for signs and symptoms of hypersensitivity during treatment with IMDELLTRA and manage as clinically indicated. Withhold or consider permanent discontinuation of IMDELLTRA based on severity.

Embryo-Fetal Toxicity: Based on its mechanism of action, IMDELLTRA may cause fetal harm when administered to a pregnant woman. Advise patients of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with IMDELLTRA and for 2 months after the last dose.
ADVERSE REACTIONS

The pooled safety population reflects exposure to intravenous IMDELLTRA, as a single agent, at the recommended dosage of IMDELLTRA 1 mg on Cycle 1 Day 1 followed by 10 mg on Days 8 and 15, and then every 2 weeks until disease progression or intolerable toxicity in 473 patients with small cell lung cancer enrolled in three clinical trials: DeLLphi-300, DeLLphi-301 and DeLLphi-304. Among 473 patients who received IMDELLTRA, 40% were exposed for 6 months or longer and 19% were exposed for greater than one year.
The most common (≥ 20%) adverse reactions were CRS (57%), fatigue (48%), decreased appetite (38%), dysgeusia (34%), pyrexia (33%), constipation (31%), musculoskeletal pain (31%) and nausea (25%).
The most common (≥ 5%) Grade 3 or 4 laboratory abnormalities were decreased lymphocytes (43%), decreased sodium (12%), decreased total neutrophils (9%) and increased uric acid (6%).
DOSAGE AND ADMINISTRATION: Important Dosing Information

Administer IMDELLTRA as an intravenous infusion over 1 hour.
Administer IMDELLTRA according to the step-up dose and schedule in the IMDELLTRA PI (Table 1) to reduce the incidence and severity of CRS.
Evaluate complete blood count, liver enzymes and bilirubin prior to administration of all doses of IMDELLTRA up through Cycle 5 Day 15 and then prior to administration of IMDELLTRA on Day 1 of each cycle starting with Cycle 6. More frequent evaluation may be necessary if clinically indicated.
For Cycle 1, administer recommended concomitant medications before and after Cycle 1 Day 1 and Cycle 1 Day 8 IMDELLTRA infusions to reduce the risk of CRS reactions as described in the PI (Table 3).
IMDELLTRA should only be administered by a qualified healthcare professional with appropriate medical support to manage severe reactions such as CRS and neurologic toxicity including ICANS.
Due to the risk of CRS and neurologic toxicity, including ICANS, monitor patients from the start of the IMDELLTRA infusion for 22 to 24 hours following Cycle 1 Day 1 and Cycle 1 Day 8 in an appropriate healthcare setting.
Recommend that patients remain within 1 hour of an appropriate healthcare setting for a total of 48 hours from the start of the infusion with IMDELLTRA following Cycle 1 Day 1 and Cycle 1 Day 8 doses, accompanied by a caregiver.
Inform both the patient and the caregiver on the signs and symptoms of CRS and ICANS prior to discharge.
Ensure patients are well hydrated prior to administration of IMDELLTRA.
Please see IMDELLTRA full Prescribing Information, including BOXED WARNINGS.

(Press release, Amgen, SEP 8, 2026, View Source [SID1234670644])

On September 8, 2026 Lunit (KRX:328130), a leading provider of AI for cancer diagnostics and precision oncology, reported the presentation of three studies at the 2026 World Conference on Lung Cancer (WCLC 2026), to be held in Seoul, South Korea, from September 12 to 15.

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Across the three studies, Lunit researchers and collaborators leveraged AI-based analysis to investigate the tumor microenvironment (TME) in non-small cell lung cancer (NSCLC), exploring its relationship with genomic characteristics and treatment response.

In the first study, researchers used Lunit SCOPE IO to analyze 494 hematoxylin and eosin (H&E)-stained whole-slide images from EGFR-mutant NSCLC cases, identifying distinct TME characteristics across mutation subtypes. Exon 19 deletion (Ex19del) tumors showed significantly lower intratumoral tumor-infiltrating lymphocyte (TIL) density, while L858R tumors showed relative enrichment of both TIL and macrophage infiltration, and exon 20 insertion (Ex20ins) tumors demonstrated higher endothelial cell density.

The findings suggest that differences in treatment outcomes across EGFR mutation subtypes may involve not only kinase kinetics but also subtype-specific characteristics of the TME.

In another study, conducted in collaboration with Paola Nisticò, M.D., of the Regina Elena National Cancer Institute in Rome, Italy researchers combined Lunit SCOPE IO with spatial transcriptomics and high-plex spatial proteomics to analyze 32 NSCLC patients treated with neoadjuvant chemo-immunotherapy. The study was conducted through the Lunit Research Program for SITC (Free SITC Whitepaper) Members, which provides eligible Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) members with research access to Lunit SCOPE IO for AI-powered tumor microenvironment analysis in cancer immunotherapy research. Tumors from patients who achieved pathological complete response (pCR) showed a highly inflamed and spatially organized microenvironment with prominent tertiary lymphoid structures (TLS), while non-pCR tumors were characterized by immune exclusion and activated fibroblast-rich stroma.

The findings highlight distinct spatial and immunological features associated with pathological response and support further investigation of spatially resolved biomarkers.

The third study evaluated an H&E-based AI model for predicting TP53 mutation status in lung adenocarcinoma. Validated in an independent cohort of 462 cases, the model achieved an area under the receiver operating characteristic curve (AUROC) of 0.759, with 82% sensitivity and 63% specificity. TME analysis further showed that TP53-mutant tumors were more frequently immune-inflamed, while TP53-wild-type tumors were characterized by immune exclusion and higher stromal fibroblast and endothelial cell densities.

The findings highlight the potential of H&E-based AI as a screening tool to enrich for patients with TP53 mutations who may be eligible for emerging clinical trials targeting specific TP53 variants.

"These studies demonstrate the expanding potential of AI-based analysis to generate deeper insights into lung cancer biology, from genomic characteristics and the tumor microenvironment to features associated with treatment response," said Brandon Suh, CEO of Lunit. "By broadening the range of insights that can be derived from routinely available pathology images, we aim to advance AI-powered biomarker discovery and patient stratification, ultimately contributing to more personalized treatment strategies for patients with cancer."

Lunit’s presentations at WCLC 2026 include:

[Poster #P3.156] AI-Powered Tumor Microenvironment Analysis Across EGFR-Mutation Subtypes in Non-Small Cell Lung Cancer, September 15, 9:30 AM KST, Exhibits and Posters, Hall C, 3F
[Poster #P2.126] Spatial Multi-Omics and AI-Driven Digital Pathology to Identify Determinants of Pathological Response to Neoadjuvant Chemo-IO in NSCLC, September 14, 10:30 AM KST, Exhibits and Posters, Hall C, 3F
[Poster #P2.134] Development of an H&E-Based Genotype Predictor and Tumor Microenvironment Analysis of TP53-Mutated Lung Adenocarcinoma, September 14, 10:30 AM KST, Exhibits and Posters, Hall C, 3F

(Press release, Lunit, SEP 8, 2026, View Source [SID1234670643])