On May 29, 2026 Johnson & Johnson (NYSE:JNJ) reported updated results from the Phase 1/1b CHRYSALIS-2 study evaluating intravenous RYBREVANT (amivantamab-vmjw) in combination with LAZCLUZE (lazertinib) in patients with advanced non-small cell lung cancer (NSCLC) with atypical epidermal growth factor receptor (EGFR) mutations. The analysis showed encouraging long-term outcomes with RYBREVANT plus LAZCLUZE in this difficult-to-treat population. Median overall survival, a secondary endpoint, was nearly 3.5 years.1 The primary endpoint of objective response rate was previously reported.2 These results add to the growing body of evidence demonstrating the potential of RYBREVANT plus LAZCLUZE to deliver durable survival outcomes across both common and atypical EGFR-mutated advanced NSCLC in the first-line setting. Data were presented in an oral session at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Abstract #8501).1

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Significant unmet need in patients with atypical EGFR-mutated NSCLC

Patients with atypical EGFR-mutated NSCLC tend to have poorer outcomes than those with common EGFR mutations (exon 19 deletions and L858R substitutions), and effective first-line treatment options remain limited.3,4 These mutations represent approximately 10-20 percent of all EGFR-mutated cases.5 Median overall survival with current standard of care single-agent therapies remains under two years, highlighting a significant unmet need for treatments that can deliver more durable benefit in this setting.6,7 RYBREVANT is designed to dual target EGFR and mesenchymal-epithelial transition (MET), while engaging the immune system.8,9,10,11 These complementary mechanisms play a central role in tumor growth and treatment resistance and may help address the underlying drivers of disease.

Expert and company perspectives supporting the strength of RYBREVANT plus LAZCLUZE

"For patients with non-small cell lung cancer harboring atypical EGFR-mutations, first-line treatment decisions are often clouded by uncertainty regarding the efficacy of currently available EGFR tyrosine kinase inhibitors," said Joel Neal,* M.D., Ph.D., principal investigator of the Phase 1/1b CHRYSALIS-2 study. "The responses we’ve seen in this trial suggest the potential for more durable disease control, and the overall survival data reinforce that picture. These long-term outcomes begin to change how we think about treatment options in managing this subtype of lung cancer." Neal is also a Professor of Medicine in the Division of Oncology at Stanford Medicine.

"Disease progression and molecular resistance remain critical barriers in EGFR-mutated non-small cell lung cancer," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson. "RYBREVANT-based combinations demonstrate the power of changing the biology by addressing multiple disease drivers from the start rather than relying on single-pathway strategies. With strong outcomes across all known EGFR mutations, this approach is raising the bar for what first-line treatment can achieve."

Detailed CHRYSALIS-2 study results

In Cohort C of the CHRYSALIS-2 study, RYBREVANT plus LAZCLUZE was evaluated as a first-line treatment in patients with atypical EGFR-mutated advanced NSCLC, excluding EGFR exon 20 insertion mutations (n=49). The most common atypical EGFR mutations included G719X (55 percent), S768X (27 percent) and L861X (24 percent), with 35 percent of patients harboring multiple atypical mutations. The study previously reported an objective response rate of 57 percent (primary endpoint).1,2

Median overall survival with RYBREVANT plus LAZCLUZE reached nearly 3.5 years (41.0 months; 95 percent confidence interval [CI], 27.7-not estimable) at a median follow-up of 31.3 months. Overall survival rates were 55 percent at three years and 46 percent at four years.1

Consistent clinical activity was observed across atypical EGFR mutation subgroups, as well as across patient and disease characteristics such as central nervous system metastases and TP53 status. Patients were also able to remain on treatment long-term across mutation groups and baseline characteristics. Notably, 41 percent of patients remained on RYBREVANT for two years or longer, further supporting the durable survival observed with this combination.1

The safety profile of RYBREVANT plus LAZCLUZE was consistent with previous reports, with no new safety signals observed with longer follow-up. Most adverse events were Grade 1 or 2. The most common treatment-emergent adverse events occurring in more than 30 percent of patients included paronychia (78 percent), rash (65 percent), hypoalbuminemia (61 percent) and infusion-related reactions (61 percent).1

RYBREVANT-based regimens are approved for patients with EGFR-mutated advanced NSCLC across common (exon 19 deletions and exon 21 L858R substitution mutations) and exon 20 insertion mutations, including in the first-line setting.12 These results further define long-term outcomes with first-line RYBREVANT plus LAZCLUZE for patients with atypical EGFR mutations. Additional data being presented at ASCO (Free ASCO Whitepaper) 2026 in lung, head and neck, and colorectal cancers underscore the broader potential of RYBREVANT across tumor types.

About the CHRYSALIS-2 Study

CHRYSALIS-2 (NCT04077463) is an open-label Phase 1/1b study to evaluate the safety and pharmacokinetics of LAZCLUZE, a third-generation EGFR-TKI, as monotherapy or in combinations with RYBREVANT, a human bispecific EGFR and cMet antibody in participants with advanced NSCLC. The study enrolled 460 patients with advanced NSCLC.13

Cohort C of the ongoing CHRYSALIS-2 study evaluates patients with atypical EGFR-mutated advanced NSCLC, excluding exon 20 insertion and classical EGFR mutations, who are treatment-naïve or have received up to two prior lines of therapy. Patients received intravenous RYBREVANT in combination with LAZCLUZE administered orally once daily.13

About Non-Small Cell Lung Cancer

Worldwide, lung cancer is one of the most common cancers, with NSCLC making up 80 to 85 percent of all lung cancer cases.14,15 The main subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma, and large cell carcinoma.16 Among the most common driver mutations in NSCLC are alterations in EGFR, which is a receptor tyrosine kinase controlling cell growth and division.17 EGFR mutations are present in 10 to 15 percent of Western patients with NSCLC with adenocarcinoma histology and occur in 40 to 50 percent of Asian patients.14,15,18,19,20,21 EGFR ex19del or EGFR L858R mutations are the most common EGFR mutations.22 The five-year survival rate for all people with advanced NSCLC and EGFR mutations treated with EGFR tyrosine kinase inhibitors (TKIs) is less than 20 percent.23,24 EGFR exon 20 insertion mutations are the third-most prevalent activating EGFR mutation.25 Patients with EGFR exon 20 insertion mutations have a real-world five-year overall survival (OS) of eight percent in the frontline setting, which is worse than patients with EGFR ex19del or L858R mutations, who have a real-world five-year OS of 19 percent.26

About RYBREVANT

RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) received U.S. FDA approval in December 2025 and is approved in multiple markets worldwide for the treatment of adults with EGFR-mutated non-small cell lung cancer (NSCLC), including those with exon 19 deletions, exon 21 L858R substitution mutations, and exon 20 insertion mutations. It is the only subcutaneous therapy approved in these populations and can be used as monotherapy or in combination with LAZCLUZE (lazertinib) or chemotherapy in the front- and second-line settings, offering convenient monthly† or bi-weekly dosing. RYBREVANT FASPRO is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE drug delivery technology.

RYBREVANT (amivantamab-vmjw), administered intravenously, received U.S. FDA approval in March 2024 and is approved for the same indications as RYBREVANT FASPRO across multiple markets. RYBERVANT is a first-in-class, fully human bispecific antibody targeting EGFR and MET, designed to inhibit tumor growth while engaging the immune system.

The effectiveness of RYBREVANT FASPRO is supported by the established clinical profile of RYBREVANT, including data from multiple Phase 3 studies such as MARIPOSA, which demonstrated improvements in progression-free and overall survival when used in combination with LAZCLUZE in first-line advanced EGFR-mutated NSCLC.

The National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines)‡ 27 include amivantamab-vmjw (RYBREVANT) across its FDA-approved treatment settings, including as a Category 1 preferred option in combination with lazertinib (LAZCLUZE) for first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations. Subcutaneous amivantamab and hyaluronidase-lpuj (RYBREVANT FASPRO) may be substituted for IV amivantamab-vmjw (RYBREVANT) where appropriate. See the latest NCCN Guidelines for NSCLC for complete information.§ ||

The NCCN Guidelines for Central Nervous System Cancers also include amivantamab (RYBREVANT)-based regimens, including in combination with lazertinib (LAZCLUZE), as the only NCCN-preferred combination options for patients with EGFR-mutated NSCLC and brain metastases.§ ||

Beyond NSCLC, RYBREVANT-based therapies are being investigated across other solid tumors, including head and neck and colorectal cancers.

The legal manufacturer for RYBREVANT is Janssen Biotech, Inc. For more information, visit www.rybrevanthcp.com.

About LAZCLUZE

In 2018, Janssen Biotech, Inc., entered into a license and collaboration agreement with Yuhan Corporation for the development of LAZCLUZE (marketed as LECLAZA in South Korea). LAZCLUZE is an oral, third-generation, brain-penetrant EGFR TKI that targets both the T790M mutation and activating EGFR mutations while sparing wild-type EGFR. An analysis of the efficacy and safety of LAZCLUZE from the Phase 3 LASER301 study was published in The Journal of Clinical Oncology in 2023.28

The legal manufacturer for LAZCLUZE is Janssen Biotech, Inc. and Yuhan Corporation.

INDICATIONS

RYBREVANT (amivantamab-vmjw) is indicated:

in combination with LAZCLUZE (lazertinib) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.
in combination with carboplatin and pemetrexed for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor.
in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test.
as a single agent for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA approved test, whose disease has progressed on or after platinum-based chemotherapy.
IMPORTANT SAFETY INFORMATION FOR RYBREVANT FASPRO AND RYBREVANT 12,29

CONTRAINDICATIONS

RYBREVANT FASPRO is contraindicated in patients with known hypersensitivity to hyaluronidase or to any of its excipients.

WARNINGS AND PRECAUTIONS

Hypersensitivity and Administration-Related Reactions with RYBREVANT FASPRO

RYBREVANT FASPRO can cause hypersensitivity and administration-related reactions (ARR); signs and symptoms of ARR include dyspnea, flushing, fever, chills, chest discomfort, hypotension, and vomiting. The median time to ARR onset is approximately 2 hours.

RYBREVANT FASPRO with LAZCLUZE

In PALOMA-3 (n=206), all Grade ARR occurred in 13% of patients, including 0.5% Grade 3. Of the patients who experienced ARR, 89% occurred with the initial dose (Week 1, Day 1).

Premedicate with antihistamines, antipyretics, and glucocorticoids and administer RYBREVANT FASPRO as recommended. Monitor patients for any signs and symptoms of administration-related reactions during injection in a setting where cardiopulmonary resuscitation medication and equipment are available. Interrupt RYBREVANT FASPRO injection if ARR is suspected. Resume treatment upon resolution of symptoms or permanently discontinue RYBREVANT FASPRO based on severity.

Infusion-Related Reactions with RYBREVANT

RYBREVANT can cause infusion-related reactions (IRR) including anaphylaxis; signs and symptoms of IRR include dyspnea, flushing, fever, chills, nausea, chest discomfort, hypotension, and vomiting. The median time to IRR onset is approximately 1 hour.

RYBREVANT with LAZCLUZE

In MARIPOSA (n=421), IRRs occurred in 63% of patients, including Grade 3 in 5% and Grade 4 in 1% of patients. IRR-related infusion modifications occurred in 54%, dose reduction in 0.7%, and permanent discontinuation of RYBREVANT in 4.5% of patients.

RYBREVANT with Carboplatin and Pemetrexed

Based on the pooled safety population (n=281), IRRs occurred in 50% of patients including Grade 3 (3.2%) adverse reactions. IRR-related infusion modifications occurred in 46%, and permanent discontinuation of RYBREVANT in 2.8% of patients.

RYBREVANT as a Single Agent

In CHRYSALIS (n=302), IRRs occurred in 66% of patients. IRRs occurred in 65% of patients on Week 1 Day 1, 3.4% on Day 2 infusion, 0.4% with Week 2 infusion, and were cumulatively 1.1% with subsequent infusions. 97% were Grade 1-2, 2.2% were Grade 3, and 0.4% were Grade 4. The median time to onset was 1 hour (range: 0.1 to 18 hours) after start of infusion. IRR-related infusion modifications occurred in 62%, and permanent discontinuation of RYBREVANT in 1.3% of patients.

Premedicate with antihistamines, antipyretics, and glucocorticoids and infuse RYBREVANT as recommended. Administer RYBREVANT via a peripheral line on Week 1 and Week 2 to reduce the risk of IRRs. Monitor patients for signs and symptoms of IRRs in a setting where cardiopulmonary resuscitation medication and equipment are available. Interrupt infusion if IRR is suspected. Reduce the infusion rate or permanently discontinue RYBREVANT based on severity. If an anaphylactic reaction occurs, permanently discontinue RYBREVANT.

Interstitial Lung Disease/Pneumonitis

RYBREVANT FASPRO and RYBREVANT can cause severe and fatal interstitial lung disease (ILD)/pneumonitis.

RYBREVANT FASPRO with LAZCLUZE

In PALOMA-3, ILD/pneumonitis occurred in 6% of patients, including Grade 3 in 1%, Grade 4 in 1.5%, and fatal cases in 1.9% of patients. 5% of patients permanently discontinued RYBREVANT FASPRO and LAZCLUZE due to ILD/pneumonitis.

RYBREVANT with LAZCLUZE

In MARIPOSA, ILD/pneumonitis occurred in 3.1% of patients, including Grade 3 in 1.0% and Grade 4 in 0.2% of patients. There was one fatal case of ILD/pneumonitis and 2.9% of patients permanently discontinued RYBREVANT and LAZCLUZE due to ILD/pneumonitis.

RYBREVANT with Carboplatin and Pemetrexed

Based on the pooled safety population, ILD/pneumonitis occurred in 2.1% of patients with 1.8% of patients experiencing Grade 3 ILD/pneumonitis. 2.1% discontinued RYBREVANT due to ILD/pneumonitis.

RYBREVANT as a Single Agent

In CHRYSALIS, ILD/pneumonitis occurred in 3.3% of patients, with 0.7% of patients experiencing Grade 3 ILD/pneumonitis. Three patients (1%) permanently discontinued RYBREVANT due to ILD/pneumonitis.

Monitor patients for new or worsening symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever). Immediately withhold RYBREVANT FASPRO or RYBREVANT and LAZCLUZE (when applicable) in patients with suspected ILD/pneumonitis and permanently discontinue if ILD/pneumonitis is confirmed.

Venous Thromboembolic (VTE) Events with Concomitant Use with LAZCLUZE

RYBREVANT FASPRO and RYBREVANT in combination with LAZCLUZE can cause serious and fatal venous thromboembolic (VTE) events, including deep vein thrombosis and pulmonary embolism. Without prophylactic anticoagulation, the majority of these events occurred during the first four months of treatment.

RYBREVANT FASPRO with LAZCLUZE

In PALOMA-3 (n=206), all Grade VTE occurred in 11% of patients and 1.5% were Grade 3. 80% (n=164) of patients received prophylactic anticoagulation at study entry, with an all Grade VTE incidence of 7%. In patients who did not receive prophylactic anticoagulation (n=42), all Grade VTE occurred in 17% of patients. In total, 0.5% of patients had VTE leading to dose reductions of RYBREVANT FASPRO and no patients required permanent discontinuation. The median time to onset of VTEs was 95 days (range: 17 to 390).

RYBREVANT with LAZCLUZE

In MARIPOSA (n=421), VTEs occurred in 36% of patients including Grade 3 in 10% and Grade 4 in 0.5% of patients. On-study VTEs occurred in 1.2% of patients (n=5) while receiving anticoagulation therapy. There were two fatal cases of VTE (0.5%), 9% of patients had VTE leading to dose interruptions of RYBREVANT, and 7% of patients had VTE leading to dose interruptions of LAZCLUZE; 1% of patients had VTE leading to dose reductions of RYBREVANT, and 0.5% of patients had VTE leading to dose reductions of LAZCLUZE; 3.1% of patients had VTE leading to permanent discontinuation of RYBREVANT, and 1.9% of patients had VTE leading to permanent discontinuation of LAZCLUZE. The median time to onset of VTEs was 84 days (range: 6 to 777).

Administer prophylactic anticoagulation for the first four months of treatment. The use of Vitamin K antagonists is not recommended.

Monitor for signs and symptoms of VTE events and treat as medically appropriate. Withhold RYBREVANT FASPRO or RYBREVANT and LAZCLUZE based on severity. Once anticoagulant treatment has been initiated, resume RYBREVANT FASPRO or RYBREVANT and LAZCLUZE at the same dose level at the discretion of the healthcare provider. In the event of VTE recurrence despite therapeutic anticoagulation, permanently discontinue RYBREVANT FASPRO or RYBREVANT. Treatment can continue with LAZCLUZE at the same dose level at the discretion of the healthcare provider. Refer to the LAZCLUZE Prescribing Information for recommended LAZCLUZE dosage modification.

Dermatologic Adverse Reactions

RYBREVANT FASPRO and RYBREVANT can cause severe rash including toxic epidermal necrolysis (TEN), dermatitis acneiform, pruritus and dry skin.

RYBREVANT FASPRO with LAZCLUZE

In PALOMA-3, rash occurred in 80% of patients, including Grade 3 in 17% and Grade 4 in 0.5% of patients. Rash leading to dose reduction occurred in 11% of patients, and RYBREVANT FASPRO was permanently discontinued due to rash in 1.5% of patients.

RYBREVANT with LAZCLUZE

In MARIPOSA, rash occurred in 86% of patients, including Grade 3 in 26% of patients. The median time to onset of rash was 14 days (range: 1 to 556 days). Rash leading to dose interruptions occurred in 37% of patients for RYBREVANT and 30% for LAZCLUZE, rash leading to dose reductions occurred in 23% of patients for RYBREVANT and 19% for LAZCLUZE, and rash leading to permanent discontinuation occurred in 5% of patients for RYBREVANT and 1.7% for LAZCLUZE.

RYBREVANT with Carboplatin and Pemetrexed

Based on the pooled safety population, rash occurred in 82% of patients, including Grade 3 (15%) adverse reactions. Rash leading to dose reductions occurred in 14% of patients, and 2.5% permanently discontinued RYBREVANT and 3.1% discontinued pemetrexed.

RYBREVANT as a Single Agent

In CHRYSALIS, rash occurred in 74% of patients, including Grade 3 in 3.3% of patients. The median time to onset of rash was 14 days (range: 1 to 276 days). Rash leading to dose reduction occurred in 5% and permanent discontinuation due to rash occurred in 0.7% of patients. Toxic epidermal necrolysis occurred in one patient (0.3%).

When initiating treatment with RYBREVANT FASPRO or RYBREVANT and LAZCLUZE, prophylactic and concomitant medications are recommended to reduce the risk and severity of dermatologic adverse reactions. Instruct patients to limit sun exposure during and for 2 months after treatment. Advise patients to wear protective clothing and use broad spectrum UVA/UVB sunscreen.

If skin reactions develop, administer supportive care including topical corticosteroids and topical and/or oral antibiotics. For Grade 3 reactions, add oral steroids and consider dermatologic consultation. Promptly refer patients presenting with severe rash, atypical appearance or distribution, or lack of improvement within 2 weeks to a dermatologist. For patients receiving RYBREVANT FASPRO or RYBREVANT in combination with LAZCLUZE, withhold, reduce the dose, or permanently discontinue both drugs based on severity. For patients receiving RYBREVANT FASPRO or RYBREVANT as a single agent or in combination with carboplatin and pemetrexed, withhold, dose reduce or permanently discontinue RYBREVANT FASPRO or RYBREVANT based on severity

Hepatotoxicity

LAZCLUZE in combination with amivantamab can cause severe hepatotoxicity (including increased ALT and AST).

RYBREVANT with LAZCLUZE

In MARIPOSA, based on adverse reaction data, hepatotoxicity occurred in 49% of patients treated with LAZCLUZE, including Grade 3 in 9.3% of patients and Grade 4 in 0.5%. LAZCLUZE was interrupted for an adverse reaction of hepatotoxicity in 8% of patients, the dose was reduced in 1.4% and permanently discontinued in 0.2%.

Perform liver function tests (including ALT, AST, and total bilirubin) before initiation of LAZCLUZE and during treatment, as clinically indicated. Withhold, reduce the dose, or permanently discontinue LAZCLUZE and amivantamab based on severity.

Ocular Toxicity

RYBREVANT FASPRO and RYBREVANT can cause ocular toxicity including keratitis, blepharitis, dry eye symptoms, conjunctival redness, blurred vision, visual impairment, ocular itching, eye pruritus and uveitis.

RYBREVANT FASPRO with LAZCLUZE

In PALOMA-3, all Grade ocular toxicity occurred in 13% of patients, including 0.5% Grade 3.

RYBREVANT with LAZCLUZE

In MARIPOSA, ocular toxicity occurred in 16%, including Grade 3 or 4 ocular toxicity in 0.7% of patients.

RYBREVANT with Carboplatin and Pemetrexed

Based on the pooled safety population, ocular toxicity occurred in 16% of patients. All events were Grade 1 or 2.

RYBREVANT as a Single Agent

In CHRYSALIS, keratitis occurred in 0.7% and uveitis occurred in 0.3% of patients. All events were Grade 1-2.

Promptly refer patients presenting with new or worsening eye symptoms to an ophthalmologist. Withhold, dose reduce or permanently discontinue RYBREVANT FASPRO or RYBREVANT and continue LAZCLUZE based on severity.

Embryo-Fetal Toxicity

Based on animal models, RYBREVANT FASPRO, RYBREVANT and LAZCLUZE can cause fetal harm when administered to a pregnant woman. Verify pregnancy status of females of reproductive potential prior to initiating RYBREVANT FASPRO and RYBREVANT. Advise pregnant women and females of reproductive potential of the potential risk to the fetus. Advise patients of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of RYBREVANT FASPRO or RYBREVANT, and for 3 weeks after the last dose of LAZCLUZE.

ADVERSE REACTIONS

RYBREVANT FASPRO with LAZCLUZE

In PALOMA-3 (n=206), the most common adverse reactions (≥20%) were rash (80%), nail toxicity (58%), musculoskeletal pain (50%), fatigue (37%), stomatitis (36%), edema (34%), nausea (30%), diarrhea (22%), vomiting (22%), constipation (22%), decreased appetite (22%), and headache (21%). The most common Grade 3 or 4 laboratory abnormalities (≥2%) were decreased lymphocyte count (6%), decreased sodium (5%), decreased potassium (5%), decreased albumin (4.9%), increased alanine aminotransferase (3.4%), decreased platelet count (2.4%), increased aspartate aminotransferase (2%), increased gammaglutamyl transferase (2%), and decreased hemoglobin (2%).

Serious adverse reactions occurred in 33% of patients, with those occurring in ≥2% of patients including ILD/pneumonitis (6%); and pneumonia, VTE and fatigue (2.4% each). Death due to adverse reactions occurred in 5% of patients treated with RYBREVANT FASPRO, including ILD/pneumonitis (1.9%), pneumonia (1.5%), and respiratory failure and sudden death (1% each).

RYBREVANT with LAZCLUZE

In MARIPOSA (n=421), the most common adverse reactions (ARs) (≥20%) were rash (86%), nail toxicity (71%), infusion-related reactions (IRRs) (RYBREVANT) (63%), musculoskeletal pain (47%), stomatitis (43%), edema (43%), VTE (36%), paresthesia (35%), fatigue (32%), diarrhea (31%), constipation (29%), COVID-19 (26%), hemorrhage (25%), dry skin (25%), decreased appetite (24%), pruritus (24%), and nausea (21%). The most common Grade 3 or 4 laboratory abnormalities (≥2%) were decreased albumin (8%), decreased sodium (7%), increased ALT (7%), decreased potassium (5%), decreased hemoglobin (3.8%), increased AST (3.8%), increased GGT (2.6%), and increased magnesium (2.6%).

Serious ARs occurred in 49% of patients, with those occurring in ≥2% of patients including VTE (11%), pneumonia (4%), ILD/pneumonitis and rash (2.9% each), COVID-19 (2.4%), and pleural effusion and IRRs (RYBREVANT) (2.1% each). Fatal ARs occurred in 7% of patients due to death not otherwise specified (1.2%); sepsis and respiratory failure (1% each); pneumonia, myocardial infarction, and sudden death (0.7% each); cerebral infarction, pulmonary embolism (PE), and COVID-19 infection (0.5% each); and ILD/pneumonitis, acute respiratory distress syndrome (ARDS), and cardiopulmonary arrest (0.2% each).

RYBREVANT with Carboplatin and Pemetrexed

In MARIPOSA-2 (n=130), the most common ARs (≥20%) were rash (72%), IRRs (59%), fatigue (51%), nail toxicity (45%), nausea (45%), constipation (39%), edema (36%), stomatitis (35%), decreased appetite (31%), musculoskeletal pain (30%), vomiting (25%), and COVID-19 (21%). The most common Grade 3 to 4 laboratory abnormalities (≥2%) were decreased neutrophils (49%), decreased white blood cells (42%), decreased lymphocytes (28%), decreased platelets (17%), decreased hemoglobin (12%), decreased potassium (11%), decreased sodium (11%), increased alanine aminotransferase (3.9%), decreased albumin (3.8%), and increased gamma-glutamyl transferase (3.1%).

In MARIPOSA-2, serious ARs occurred in 32% of patients, with those occurring in >2% of patients including dyspnea (3.1%), thrombocytopenia (3.1%), sepsis (2.3%), and PE (2.3%). Fatal ARs occurred in 2.3% of patients; these included respiratory failure, sepsis, and ventricular fibrillation (0.8% each).

In PAPILLON (n=151), the most common ARs (≥20%) were rash (90%), nail toxicity (62%), stomatitis (43%), IRRs (42%), fatigue (42%), edema (40%), constipation (40%), decreased appetite (36%), nausea (36%), COVID-19 (24%), diarrhea (21%), and vomiting (21%). The most common Grade 3 to 4 laboratory abnormalities (≥2%) were decreased albumin (7%), increased alanine aminotransferase (4%), increased gamma-glutamyl transferase (4%), decreased sodium (7%), decreased potassium (11%), decreased magnesium (2%), and decreases in white blood cells (17%), hemoglobin (11%), neutrophils (36%), platelets (10%), and lymphocytes (11%).

In PAPILLON, serious ARs occurred in 37% of patients, with those occurring in ≥2% of patients including rash, pneumonia, ILD, PE, vomiting, and COVID-19. Fatal adverse reactions occurred in 7 patients (4.6%) due to pneumonia, cerebrovascular accident, cardio-respiratory arrest, COVID-19, sepsis, and death not otherwise specified.

RYBREVANT as a Single Agent

In CHRYSALIS (n=129), the most common ARs (≥20%) were rash (84%), IRR (64%), paronychia (50%), musculoskeletal pain (47%), dyspnea (37%), nausea (36%), fatigue (33%), edema (27%), stomatitis (26%), cough (25%), constipation (23%), and vomiting (22%). The most common Grade 3 to 4 laboratory abnormalities (≥2%) were decreased lymphocytes (8%), decreased albumin (8%), decreased phosphate (8%), decreased potassium (6%), increased alkaline phosphatase (4.8%), increased glucose (4%), increased gamma-glutamyl transferase (4%), and decreased sodium (4%).

Serious ARs occurred in 30% of patients, with those occurring in ≥2% of patients including PE, pneumonitis/ILD, dyspnea, musculoskeletal pain, pneumonia, and muscular weakness. Fatal adverse reactions occurred in 2 patients (1.5%) due to pneumonia and 1 patient (0.8%) due to sudden death.

LAZCLUZE DRUG INTERACTIONS

Avoid concomitant use of LAZCLUZE with strong and moderate CYP3A4 inducers. Consider an alternate concomitant medication with no potential to induce CYP3A4.

Monitor for adverse reactions associated with a CYP3A4 or BCRP substrate where minimal concentration changes may lead to serious adverse reactions, as recommended in the approved product labeling for the CYP3A4 or BCRP substrate.

(Press release, Johnson & Johnson, MAY 29, 2026, View Source [SID1234666222])

On May 29, 2026 Experts from NYU Langone Health’s Perlmutter Cancer Center, a National Cancer Institute–designated Comprehensive Cancer Center, reported their latest clinical findings and research at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, held May 29 to June 2 in Chicago.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Our dedication to leading-edge research ensures that patients receive the most current and effective care available," said Anirban Maitra, MD, director of Perlmutter Cancer Center. "By integrating personalized patient care with the expertise of our multidisciplinary teams, groundbreaking research, and clinical trials, we are able to offer access to the newest treatment options and advances in cancer care."

NYU Langone Health faculty are presenting more than 20 posters and oral abstracts and leading several educational sessions at the meeting. Below is a snapshot of some of the work that will be discussed.

First Randomized Phase 3 Trial in This Rare Skin Cancer Shows Improvement in Quelling Metastasis (Abstract LBA9505)

Janice Mehnert, MD, director of the melanoma medical oncology program and associate director of clinical research at Perlmutter Cancer Center, and her team have found that patients with Merkel cell carcinoma (MCC), a rare and aggressive skin cancer that carries a high risk of relapse, experienced fewer MCC-related recurrences and deaths after receiving pembrolizumab postsurgery than those who received standard care alone, supporting a potential new adjuvant treatment option for this difficult disease.

The first randomized phase 3 clinical trial, known as EA6174 or STAMP, enrolled 293 patients who’d had surgery to remove their MCC and randomly assigned them to receive either pembrolizumab every three weeks for up to 17 doses or standard care after surgery. Most participants had stage 3 disease, and researchers assessed whether pembrolizumab could affect their chances of relapse, overall survival, and other disease-specific outcomes. While the broadest relapse-free survival data showed some improvement, it did not meet statistical significance. However, pembrolizumab significantly reduced the risk of distant spread of the cancer.

Investigators also examined the role of radiation therapy in treatment outcomes. Among patients who received radiation therapy, the benefit of pembrolizumab was maintained overall. The strongest effect was seen in patients who received radiation before starting pembrolizumab: The treatment improved relapse-free and distant-metastasis-free outcomes. Pembrolizumab did not appear to improve outcomes when given concurrently with radiation.

Longer follow-up will be needed to determine the treatment’s effect on overall survival.

National Analysis Finds Income-Related Gaps in Lung Cancer Survival Have Widened Since Screening Guidelines Introduced (Abstract 8072)

A new national study suggests that while lung cancer screening has helped more patients receive earlier diagnoses and live longer, the benefits are not equal across income groups. Senior author Daniel J. Becker, MD, clinical associate professor of medicine at NYU Grossman School of Medicine, and his coauthors found that since the introduction of U.S. Preventive Services Task Force (USPSTF) lung cancer screening guidelines in 2013, patients in all income categories were more likely to be diagnosed at an earlier stage and had better survival. However, survival improvements were greater in wealthier communities, widening existing income-related disparities.

Using national cancer incidence, survival, and demographic data, investigators analyzed nearly 1 million lung cancer cases diagnosed between 2005 and 2022, comparing outcomes before screening guidelines were introduced (from 2005 to 2013) with outcomes after screening began (from 2014 to 2022). Across all county income levels, more patients were diagnosed with early-stage disease in the screening era. But the increase was smaller in the lowest-income areas than in the highest-income areas. Median survival also improved in every income group, rising by two months in the lowest-income group and by eight months in the highest-income group.

In adjusted analyses, the researchers found that the survival gap between patients living in the highest- and lowest-income counties was 12.2 percent larger in the screening era than in the years before guideline adoption. The findings suggest that although lung cancer screening is associated with meaningful population-level benefits, additional efforts are needed to make sure access to screening, early detection, and follow-up care reaches underserved communities as effectively as it reaches wealthier ones.

This study will be presented by Tyler Healy, MD, internal medicine resident at NYU Grossman School of Medicine.

Study Identifies New Way to Predict Outcomes in Advanced Prostate Cancer (Abstract 5074)

Researchers have developed a new model that may improve how doctors predict outcomes for patients with metastatic castration-resistant prostate cancer (mCRPC), an advanced form of prostate cancer known for its biological complexity and variable response to treatment. Investigators created a prognostic tool that outperformed several commonly used gene expression signatures in identifying higher-risk disease.

The study used data from patients in a cohort tracked by Stand Up to Cancer and applied computational methods to infer the activity of on-off switches of tumor behavior called transcriptional regulators. The resulting machine-learning model showed strong performance, suggesting that this approach may be a reliable way to classify patients according to risk. Among the most informative features were regulators and genomic alterations tied to aggressive prostate cancer biology, along with clinical factors such as prior therapy and age.

This study’s senior author is David R. Wise, MD, PhD, an associate professor of medicine and urology and the service chief of the genitourinary medical oncology program at Perlmutter Cancer Center. It will be presented by Aaron Griffin, MD, PhD, internal medicine resident at NYU Grossman School of Medicine.

The researchers say the findings highlight the value of looking beyond standard gene expression patterns to better understand the underlying biology of advanced prostate cancer. In addition to improving prognostication, the analysis revealed distinct regulatory states associated with more aggressive and treatment-resistant disease. The authors conclude that this strategy could provide a stronger framework for risk stratification in mCRPC and may help guide future efforts to personalize treatment for patients with advanced prostate cancer.

Study Links Earlier Immunotherapy Infusion Timing to Lower Recurrence Risk in Triple-Negative Breast Cancer (Abstract 594)

Researchers have found that the timing of immunotherapy infusions may be associated with outcomes in patients with early-stage triple-negative breast cancer (TNBC) receiving neoadjuvant treatment. In a retrospective study of 139 patients treated with a regimen at Perlmutter Cancer Center sites, patients who received their first three immunotherapy infusions earlier in the day had a significantly lower risk of recurrence than those treated later, raising the possibility that circadian timing may affect the benefit of immune checkpoint blockade.

Corresponding author Iris Zhi, MD, PhD, medical director of clinical operations for medical oncology and interim chief of hematology and medical oncology at Perlmutter Cancer Center—Long Island, and other investigators analyzed patients treated between July 2021 and June 2025 and divided them into early and late infusion groups using the cohort’s median infusion time of 12:22 p.m. While the difference in pathologic complete response rates did not reach statistical significance, outcomes favored earlier treatment, with the total disappearance of cancer cell rates of 63 percent in the early group versus 45.2 percent in the late group. Recurrence rates were significantly lower among patients treated earlier in the day, at 3.7 percent compared with 16.1 percent in the late-treatment group, an effect driven largely by lower rates of distant recurrence.

After adjusting for baseline clinical factors, later immunotherapy timing remained associated with a markedly higher risk of distant recurrence. The authors conclude that circadian timing of immunotherapy may influence long-term outcomes beyond pathologic response, and the findings support further study of treatment timing as a potentially modifiable factor in early-stage TNBC care.

This study will be presented by lead author Xianghui Zou, MD, PhD, hematology and oncology fellow at NYU Grossman Long Island School of Medicine.

Study Evaluates Novel CAR T-Cell Therapy for Advanced Solid Tumors (Abstract TPS2673)

Salman R. Punekar, MD, assistant professor of medicine at NYU Grossman School of Medicine, will present a study on a new type of CAR T-cell therapy for patients with advanced solid tumors in a first-in-human phase 1/2 clinical trial in progress. The study, called EVEREST-2, is testing A2B543, an investigational "logic-gated" CAR T-cell therapy designed to better distinguish cancer cells from healthy tissue by targeting tumors that express a cancer cell target called mesothelin, among other factors. The therapy also includes a booster intended to strengthen antitumor activity while reducing toxic effects.

The trial is enrolling adults with unresectable locally advanced recurrent or metastatic solid tumors, including pancreatic tumors; non-small cell lung, colorectal, ovarian, and mesothelioma tumors; and other mesothelin-expressing tumors. In the phase 1 portion, investigators are assessing safety, tolerability, and the recommended phase 2 dose, while the phase 2 portion will evaluate efficacy.

The treatment is intended to expand the potential of CAR T-cell therapy in solid tumors, where on-target, off-tumor toxicity has limited progress. Early findings from related studies have shown manageable safety and tolerability, and investigators say the EVEREST-2 trial will help determine whether this can further improve the potency and persistence of this tumor-selective platform. Enrollment is ongoing.

(Press release, NYU Langone Health, MAY 29, 2026, View Source [SID1234666221])

On May 29, 2026 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company", 6990.HK) reported that at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting held in Chicago, USA, results from the pivotal Phase II study of the Company’s next-generation selective RET inhibitor, lunbotinib fumarate (A400/EP0031, 宁泰莱[1]), in advanced rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) were presented as an oral report by Professor Qing Zhou from Guangdong Provincial People’s Hospital (Abstract #8505, Lung Cancer—Metastatic Non-Small Cell). Based on these results, a New Drug Application (NDA) for lunbotinib fumarate for the treatment of adult patients with locally advanced or metastatic RET fusion-positive NSCLC has been accepted by the National Medical Products Administration (NMPA) of China.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The study enrolled 71 patients who had previously received platinum-based chemotherapy and immunotherapy (pre-treated patients) and 92 patients who had not received prior systemic therapy (treatment-naïve patients). As of the data cutoff date of October 29, 2025, the median follow-up was 22.6 months and 20.7 months, respectively.

The confirmed objective response rate (ORR) assessed by Independent Review Committee (IRC) was 81.3% (95% CI: 71.8–88.7) in treatment-naïve patients and 87.1% (95% CI: 77.0–93.9) in pre-treated patients.

In treatment-naïve patients, median duration of response (mDOR) and median progression-free survival (mPFS) were not reached. In pre-treated patients, mDOR was 25.7 months, and mPFS was 27.5 months.

Among 40 patients with central nervous system (CNS) metastases at baseline (assessed by IRC per response assessment in neuro-oncology brain metastases (RANO-BM) criteria), the intracranial complete response (CR) rate was 30%, and the disease control rate (DCR) was 92.5% (95% CI: 79.6–98.4).

Lunbotinib fumarate was well tolerated, with treatment-related adverse events (TRAEs) being predominantly Grade 1–2. The rate of permanent discontinuation due to TRAEs was 1.2%, and no treatment-related deaths were reported.

The study shows that lunbotinib fumarate demonstrated robust and durable clinical activity in RET fusion-positive NSCLC, regardless of line of therapy, in a largely poor-prognostic patient population. Favorable CNS efficacy was observed in patients with measurable baseline CNS metastases. The safety profile was manageable, with no unexpected safety signals.

Professor Qing Zhou, principal investigator from Guangdong Provincial People’s Hospital, said: "From the first presentation of Phase I data at ASCO (Free ASCO Whitepaper) 2023 to today’s pivotal Phase II results, we have witnessed the progression of lunbotinib fumarate from early exploration to a confirmatory study. These data show that lunbotinib fumarate delivers robust and durable responses in both treatment-naïve and pre-treated patients with RET fusion-positive NSCLC, with particularly remarkable intracranial efficacy in patients with CNS metastases at baseline. As a next-generation selective RET inhibitor, it will offer an important new treatment option for patients."

About lunbotinib fumarate (A400/EP0031, 宁泰莱)

Lunbotinib fumarate is a novel, next-generation selective RET inhibitor for NSCLC, medullary thyroid cancer (MTC) and other solid tumors with a high prevalence of RET alterations. The NDA of lunbotinib fumarate has been accepted for review by the NMPA of China for the treatment of adult patients with RET-fusion positive locally advanced or metastatic NSCLC. The Company is also conducting a Phase Ib/II clinical study in China for the treatment of RET-positive solid tumors.

In March 2021, the Company granted Ellipses Pharma Limited, a U.K.-based international oncology drug development company, an exclusive license to develop, manufacture and commercialize this agent outside Greater China and certain Asian countries. In April 2024, lunbotinib fumarate was cleared by the Food and Drug Administration (FDA) to progress into a Phase II clinical trial (NCT05443126) which is currently recruiting in the United States, United Kingdom, Europe and United Arab Emirates, where it is being evaluated as a monotherapy and in combination with chemotherapy in RET fusion positive advanced NSCLC.

(Press release, Kelun, MAY 29, 2026, View Source [SID1234666219])

On May 29, 2026 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company", 6990.HK) reported that at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, the results of the Phase III clinical study OptiTROP-Lung05, evaluating the company’s TROP2 ADC sacituzumab tirumotecan (sac-TMT, also known as SKB264/MK-2870)(佳泰莱) in combination with pembrolizumab (KEYTRUDA[1], MSD’s anti-programmed cell death protein 1 (PD-1) antibody) as first-line treatment for Programmed Death-Ligand 1 (PD-L1) Tumor Proportion Score (TPS)≥1% non-small cell lung cancer (NSCLC), was presented as an oral presentation by Professor Caicun Zhou from Shanghai East Hospital, Tongji University (Abstract #8506, Lung Cancer – Metastatic Non-Small Cell).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Sac-TMT is designed with a unique, bifunctional linker and differentiated belotecan-derivative payload. The linker is conjugated via cysteine, which maximizes payload delivery to tumor cells both through its irreversible connection with the high-affinity and targeting anti-TROP2 monoclonal antibody sacituzumab and its pH-sensitive cleavage from a moderately toxic novel topoisomerase I inhibitor payload in the lysosome, with a drug-to-antibody-ratio (DAR) of 7.4.

In the OptiTROP-Lung05 study, a total of 413 patients were randomized (1:1) to receive either sac-TMT in combination with pembrolizumab or pembrolizumab monotherapy.

As of the data cutoff date (September 29, 2025), with a median follow‑up of 10.5 months, the study demonstrated that:

Progression-free survival (PFS) showed statistically significant and clinically meaningful benefit in sac-TMT plus pembrolizumab compared with pembrolizumab alone. The median PFS assessed by blinded independent central review (BICR) was not reached (NR) vs 5.7 months (HR=0.35; 95% CI: 0.26-0.47; p<0.0001). The 12-month PFS rate was 62.4% vs 29.0%.
Consistent benefit across prespecified subgroups: In patients with PD‑L1 TPS ≥50% and TPS 1–49%, the PFS HRs were 0.47 (95% CI: 0.29–0.77) and 0.28 (95% CI: 0.19–0.41), respectively. In patients with non‑squamous and squamous NSCLC, the PFS HRs were 0.28 (95% CI: 0.18–0.43) and 0.44 (95% CI: 0.29–0.66), respectively.
Overall survival (OS) was not yet mature but showed a positive trend: median OS was NR vs 14.5 months (HR = 0.55; 95% CI: 0.36–0.85). The 12‑month OS rate was 80.4% vs 68.9%.
The combination group showed improvements over pembrolizumab monotherapy group in objective response rate (ORR) (70.2% vs 42.0%), deep response rate (49.0% vs 25.9%), and 12-month duration of response rate (77.7% vs 59.4%).
The incidence of grade ≥3 treatment-emergent adverse events (TEAEs) was higher in the combination group, primarily driven by the expected hematologic adverse events of sac-TMT. Incidence of discontinuation of pembrolizumab due to TEAEs was similar in both groups. No sac-TMT-related deaths occurred. Adverse events of special interest (AEOSIs) were consistent with the known safety profiles of each individual agent, and no new safety signals were identified.

The interim analysis results show that sac-TMT plus pembrolizumab significantly prolonged PFS and reduced the risk of disease progression or death compared with pembrolizumab alone, with consistent PFS benefits observed across all prespecified subgroups (including PD‑L1 expression levels and histological subtypes). A positive trend in OS was also observed. Furthermore, the overall safety profile of sac-TMT in combination with pembrolizumab was manageable, consistent with the established safety profiles of sac-TMT alone or pembrolizumab alone.

Notably, the findings of OptiTROP-Lung05 have been simultaneously published in The Lancet（Impact Factor=88.5）, indicating that its clinical and academic value has received dual recognition from a leading international academic conference and an authoritative journal.

Professor Caicun Zhou, the national leading principal investigator from Shanghai East Hospital, Tongji University, said: "The positive results of the OptiTROP‑Lung05 study are encouraging. The study not only supports the application of sac‑TMT in an earlier-line setting for lung cancer, but also provides evidence of the ‘ADC+IO’ synergistic strategy being evaluated in the first-line setting for PD‑L1‑positive advanced NSCLC, potentially bringing a new option to a broad population of patients with lung cancer."

About sac-TMT

Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as NSCLC, breast cancer (BC), gastric cancer (GC), gynecological tumors and genitourinary tumors, among others. Sac-TMT is developed with a unique, bifunctional linker that maximizes payload delivery to tumor cells both through its irreversible connection with the anti-TROP2 monoclonal antibody sacituzumab and its pH-sensitive cleavage from a belotecan-derivative topoisomerase I inhibitor payload in the lysosome, with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases the payload KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells.

In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc, Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (which includes Mainland China, Hong Kong, Macao and Taiwan).

To date, four indications for sac-TMT have been approved and marketed in China for: 1) unresectable locally advanced or metastatic triple‑negative breast cancer (TNBC) who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting); 2) EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC following progression on epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) therapy and platinum-based chemotherapy; 3) epidermal growth factor receptor (EGFR) mutant-positive locally advanced or metastatic non-squamous NSCLC who progressed after treatment with EGFR-TKI therapy; 4) unresectable or metastatic hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) (Immunohistochemistry (IHC) 0, IHC 1+ or IHC 2+/In Situ Hybridization (ISH)-) BC who have received prior endocrine therapy and at least one line of chemotherapy in advanced setting. The first two indications above have been included in China’s National Reimbursement Drug List (NRDL). This inclusion is expected to bring clinically meaningful benefits to a greater number of patients with BC and NSCLC. Additionally, sac-TMT has been granted six Breakthrough Therapy Designations (BTDs) by the National Medical Products Administration (NMPA).

Sac-TMT is the world’s first TROP2 ADC drug approved for marketing in lung cancer. A new indication application for sac-TMT in combination with pembrolizumab (KEYTRUDA) as first‑line treatment for locally advanced or metastatic NSCLC who have PD-L1 TPS≥1% and are EGFR-negative and anaplastic lymphoma kinase (ALK)-negative has been accepted for review by the NMPA, and has entered the priority review and approval process. As of today, Kelun-Biotech has initiated 9 registrational clinical studies in China. MSD is evaluating 17 ongoing global Phase III clinical studies of sac-TMT as a monotherapy or in combination with pembrolizumab or other anti-cancer agents for several types of cancer. These studies are sponsored and led by MSD.

(Press release, Kelun, MAY 29, 2026, View Source [SID1234666216])

On May 29, 2026 Actinium Pharmaceuticals, Inc. (NYSE American: ATNM) (Actinium or the Company), a leader in the development of targeted radiotherapies, reported it will provide a program update on its first-in-class Actinium-225 (225Ac) antibody radioconjugate, ATNM-400, highlighting new data that will be showcased across three presentations at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2026 Annual Meeting, taking place May 30-June 2, 2026, in Los Angeles, California. Two of the presentations showcase ATNM-400’s differentiated profile across prostate cancer and non-small cell lung cancer (NSCLC), while a third demonstrates the importance of radioconjugate optimization for radiotherapies in the context of the Company’s pipeline candidates.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

With the SNMMI 2026 program now finalized, the Company is providing updated presentation details, including poster titles, presenters, dates, and times. The data to be presented reinforce the meaningful progress of the ATNM-400 program and its potential as a mutation-agnostic, pan-tumor therapy, while also demonstrating the strength of the underlying radioconjugate platform that supports Actinium’s broader pipeline. The Company anticipates multiple catalysts for ATNM-400, Actimab-A and Iomab-ACT in 2H:2026 that are expected to demonstrate the clinical potential of these programs.

ATNM-400 SNMMI 2026 Presentation Details

Poster Title: ATNM-400: A First-in-Class Non-PSMA Actinium-225 Antibody Radioconjugate Demonstrates Superior Efficacy to PSMA-617 Radioligands and ARPIs With Favorable Safety Profile in Prostate Cancer Models
Presenter: Sumit Mukherjee Ph.D., Actinium Pharmaceuticals, Inc.
Session: Oncology: Discovery & Translational Meet the Author Session
Date & Time: Tuesday, June 2, 2026 11:30am-12:15pm PT | Los Angeles, California

Poster Title: ATNM-400: A First-in-Class Actinium-225 Antibody Radioconjugate Demonstrating Durable, Mutation-Agnostic Anti-Tumor Activity in Non-Small Cell Lung Cancer Models
Presenter: Shiva Kazerounian Ph.D., Actinium Pharmaceuticals, Inc.
Session: Oncology: Discovery & Translational Meet the Author Session
Date & Time: Tuesday, June 2, 2026, 11:30am-12:15pm PT | Los Angeles, California

Poster Title: Optimizing Chelator-to-Antibody Ratio Improves Tumor Targeting and Pharmacokinetics of 225Ac-Labeled Antibodies
Presenter: Shiva Kazerounian Ph.D., Actinium Pharmaceuticals, Inc.
Session: MTA05 RPSC/CMIIT POPs and Science Pavilion Mixer
Date & Time: Sunday, May 31, 2026, 7:30-8:00pm PT | Los Angeles, California

The posters will be available on the Company website shortly after the presentations at View Source

NYSE American Continued Listing Standards Notice
Actinium also announced today that it has received a notice (the "Notice") from the NYSE American LLC ("NYSE American") indicating that the Company is not in compliance with the continued listing standards set forth in Section 1003(a)(ii) of the NYSE American Company Guide (the "Company Guide"), which requires a listed company to maintain stockholders’ equity of $4.0 million or more if it has reported losses from continuing operations and/or net losses in three of its four most recent fiscal years. As of March 31, 2026, the Company reported stockholders’ equity of approximately $2.3 million and had net losses in its last five fiscal years ended December 31, 2025. The Notice also indicates that the Company is also not currently eligible for any exemption in Section 1003(a) of the Company Guide. The notice has no immediate effect on the listing or trading of the Company’s common stock on the NYSE American and the Company’s shares will continue to trade under the symbol "ATNM," subject to compliance with other listing requirements of the Company Guide.

In connection with the non-compliance with Sections 1003(a)(ii) and (iii) of the Company Guide, the Company must submit a compliance plan by June 26, 2026, advising of actions the Company has taken or will take to regain compliance with the continued listing standards by November 27, 2027 (the "Plan Period Deadline"). If the NYSE American determines to accept the plan, the Company will be notified in writing and will be subject to periodic reviews, including quarterly monitoring, for compliance with the plan.

If the Company does not submit a plan or if the plan is not accepted, delisting proceedings will commence. Furthermore, if the plan is accepted but the Company is not in compliance with the continued listing standards by the Plan Period Deadline which is eighteen months from the receipt of the notice or November 27, 2027, or if the Company does not make progress consistent with the plan during the plan period, Exchange staff will initiate delisting proceedings as appropriate. The Company may appeal a staff delisting determination in accordance with Section 1010 and Part 12 of the Company Guide.

Actinium currently intends to submit a plan to regain compliance within the required timeframe. There can be no assurance that the Company will be able to achieve compliance with the NYSE American’s continued listing standards within the required timeframe of eighteen months from date of receipt of the notice or November 27, 2027.

(Press release, Actinium Pharmaceuticals, MAY 29, 2026, View Source [SID1234666206])