On September 14, 2026 Johnson & Johnson (NYSE:JNJ) reported new results from the Phase 2b COPERNICUS study evaluating how subcutaneous RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) plus LAZCLUZE (lazertinib), with less frequent dosing and prophylactic strategies, can improve the treatment experience for patients with previously untreated advanced non-small cell lung cancer (NSCLC) with common epidermal growth factor receptor (EGFR) mutations. Early results show consistently low rates across key treatment-related events and treatment discontinuation.1

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COPERNICUS was designed to reflect everyday clinical practice, enrolling a racially and ethnically diverse patient population across both academic and community sites. The data were presented at the International Association for the Study of Lung Cancer (IASLC) 2026 World Conference on Lung Cancer (WCLC) (Abstract #M012.09).1

RYBREVANT FASPRO dual-targets EGFR and mesenchymal-epithelial transition (MET), two key drivers of tumor growth and treatment resistance, while also engaging the immune system.2,3,4,5 It is approved across multiple EGFR-mutated advanced NSCLC treatment settings and, for eligible patients, offers once-monthly dosing following initial weekly dosing.6

Advancing the treatment experience with RYBREVANT-based regimens

"RYBREVANT plus LAZCLUZE has already shown that patients with EGFR-mutated lung cancer can live longer, and these latest results mark an important evolution in the treatment approach," said Balazs Halmos, M.D., M.S., Director of Thoracic Oncology and Associate Director of Clinical Science, Montefiore Einstein Comprehensive Cancer Center. "With subcutaneous administration, less frequent dosing and prophylactic strategies, the regimen has been developed with the treatment experience in mind, helping patients start treatment and stay on it."

"Our work with RYBREVANT in EGFR-mutated lung cancer has continued to evolve with each new piece of evidence, from extending survival to advancing how treatment is delivered and managed," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson. "COPERNICUS brings those learnings together in a study designed around the realities of clinical care. It reflects our commitment to continually innovate across the treatment journey so that scientific advances can make a meaningful difference for more patients."

Detailed study results

In this analysis, 214 U.S. patients received the recently approved RYBREVANT FASPRO plus LAZCLUZE regimen with prophylactic strategies to reduce the risk of blood clots with oral anticoagulation and skin-related side effects with an enhanced, easy-to-use skin care regimen evaluated in the COCOON study.1,7

At a median follow-up of 8.3 months, the majority of adverse events were Grade 1 or 2, with no new safety signals observed. Only eight percent of patients discontinued treatment due to adverse events. Rash was reported in 25 percent of patients, while administration-related reactions (ARRs) and venous thromboembolism (VTE) were each reported in three percent. No patients discontinued due to ARRs, and one percent discontinued due to rash and VTE.1

These findings represent lower numerical rates than observed with intravenous RYBREVANT (amivantamab-vmjw) plus LAZCLUZE in the Phase 3 MARIPOSA study, where rash, ARRs and VTE during the first four months of treatment were reported in 55 percent, 55 percent and 23 percent of patients, respectively. MARIPOSA also demonstrated that patients with advanced EGFR-mutated advanced NSCLC treated with the first-line regimen lived longer than those treated with osimertinib, with a statistically significant overall survival benefit (hazard ratio [HR], 0.75; P=0.005).8

COPERNICUS is one of the largest global studies conducted in patients with EGFR-mutated NSCLC, with a target enrollment of 300 previously untreated patients. Of the population reported here, median age was 67 years, 22 percent were age 75 or older, 27 percent were Asian, 10 percent were African American and 10 percent were Hispanic/Latino.1

This study reflects Johnson & Johnson’s continued focus on improving the treatment experience for people with cancer, including how treatments are delivered and managed in everyday care.

About the COPERNICUS study

COPERNICUS (NCT06667076) is a Phase 2b, single-arm study evaluating RYBREVANT FASPRO plus LAZCLUZE with prophylactic strategies in patients with EGFR-mutated advanced non-small cell lung cancer. Cohort 1 evaluates the regimen in the first-line setting, incorporating once-every-four-weeks dosing, venous thromboembolism (VTE) and enhanced dermatologic prophylaxis.

The study uses a pragmatic design to more closely reflect real-world clinical practice, with participation from academic and community sites and reduced visit frequency. The primary endpoint is investigator-assessed progression-free survival per RECIST v1.1. Secondary endpoints include safety and tolerability measures, including VTE and dermatologic adverse events and administration-related reactions, as well as overall survival and overall response rate.9

About non-small cell lung cancer

Worldwide, lung cancer is one of the most common cancers, with non-small cell lung cancer (NSCLC) making up 80 to 85 percent of all lung cancer cases.10,11 The main subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma, and large cell carcinoma.12 Among the most common driver mutations in NSCLC are alterations in EGFR, which is a receptor tyrosine kinase controlling cell growth and division.13 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.10,11,14,15,16,17 EGFR ex19del or EGFR L858R mutations are the most common EGFR mutations.18 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.19,20 EGFR exon 20 insertion mutations are the third-most prevalent activating EGFR mutation.21 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.22

About RYBREVANT FASPRO and 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 for these EGFR-mutated NSCLC populations and may be used as monotherapy or in combination with LAZCLUZE (lazertinib) or chemotherapy, depending on the specific mutation and treatment setting. For eligible patients, RYBREVANT FASPRO offers a once-monthly dosing option following initial weekly dosing. RYBREVANT FASPRO is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE drug delivery technology.

RYBREVANT FASPRO is approved in the U.S. for the same indications as intravenous RYBREVANT (amivantamab-vmjw) across multiple markets. RYBREVANT 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)‡ 23 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 FASPRO and RYBREVANT is Janssen Biotech, Inc. For more information, visit www.rybrevanthcp.com.

INDICATIONS

RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) and RYBREVANT (amivantamab-vmjw) are 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 6,24

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 gamma-glutamyl 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, SEP 14, 2026, View Source [SID1234670838])

On September 14, 2026 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) , a leading innovative, commercial-stage global biotech company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for autoimmune diseases, solid tumors and hematological malignancies indications, reported that a preclinical research paper evaluating the combination of ATG-037 (CD73 Small Molecule Inhibitor) and selinexor for the treatment of multiple myeloma (MM), conducted in collaboration with the Department of Hematology at Peking University Third Hospital, has been published in Cancer Gene Therapy, an international SCI journal under Springer Nature.

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Details of the Paper
Title: CD73 inhibitor enhances the antitumor activity of selinexor in multiple myeloma by restoring the activation of CD8+ T cells
Journal: Cancer Gene Therapy
DOI: 10.1038/s41417-026-01078-9

Study Design:

The research team first analyzed CD73 expression across multiple tumor cell lines following selinexor treatment, then tested the combination in vivo using a J558-inoculated BALB/c mouse model, with mice divided into a vehicle group, an ATG-037 monotherapy group, a selinexor monotherapy group and a combination-therapy group. Single-cell RNA sequencing was used to characterize immune cell subtypes and tumor-immune crosstalk, immunofluorescence staining was performed on tumor tissue, and a co-culture model of CD8+ T cells and multiple myeloma cell lines was established to confirm the mechanism behind the combination’s antitumor effect.

Key Findings:

Selinexor treatment was found to upregulate CD73 expression in the majority of tumors, a resistance-associated mechanism that the combination approach was designed to counter. In the mouse model, the combination therapy suppressed tumor growth with an inhibition rate of 62%, compared with 31% for ATG-037 monotherapy and 43% for selinexor monotherapy. Single-cell RNA sequencing showed that the combination synergistically potentiated CD8+ T cell activation by enhancing the interaction between CD8+ T cells and Enpp1+ cells via the CD80–CD28 signaling pathway, and the resulting increase in CD8+ T cell infiltration into tumor tissue was confirmed by immunofluorescence staining. In co-culture experiments, CD73 inhibition was shown to strengthen selinexor-mediated tumor cell killing by activating CD8+ T cells, with significantly elevated levels of Granzyme B (P=0.0252) and IFN-γ (P=0.0067) observed in the combination group.

Conclusion:

The study highlights the synergistic potential of combining selinexor with a CD73 inhibitor for enhancing CD8+ T cell-mediated tumor cytotoxicity in MM. Selinexor therapy upregulates CD73 in the TME, driving adenosine accumulation and an immunosuppressive state. Combined use of ATG-037 blocks this immunosuppressive feedback loop via suppression of CD73-dependent adenosine synthesis, restoring CD8+ T cell activation and proliferation while enhancing T cell cytotoxicity through activation of the CD80-CD28 costimulatory axis. These findings establish a novel, clinically feasible therapeutic paradigm for addressing drug resistance and refractory MM.

(Press release, Antengene, SEP 14, 2026, View Source [SID1234670836])

On September 14, 2026 Sapience Therapeutics, Inc., a clinical-stage biotechnology company dedicated to developing first-in-class peptide therapeutics targeting the underlying oncogenic and immune mechanisms driving cancer and pre-cancerous disease, reported that the U.S. Food and Drug Administration (FDA) has granted the Company an Investigational New Drug (IND) application for ST316 (IND 184073) for the treatment of familial adenomatous polyposis (FAP), a rare inherited disorder associated with the development of hundreds to thousands of precancerous colorectal polyps and a significantly increased risk of colorectal cancer.

Schedule your 30 min Free 1stOncology Demo!
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ST316 has previously received Orphan Drug designation from the FDA for the treatment of familial adenomatous polyposis.

"We are pleased to reach this important regulatory milestone for ST316," said Barry Kappel, Chief Executive Officer of Sapience Therapeutics. "ST316’s unique mechanism of action is designed to selectively inhibit oncogenic β-catenin activity while avoiding the toxicities associated with broader Wnt pathway inhibition. The favorable safety and tolerability profile observed with ST316 monotherapy in the Phase 1 clinical study strengthens the potential of this differentiated approach, particularly in FAP, where long-term treatment requires a high bar for safety and tolerability. Together with supportive preclinical activity in FAP models of disease, we believe ST316 has the potential to become an important new therapeutic option for patients with this serious inherited condition."

ST316 has already demonstrated encouraging clinical activity in an ongoing Phase 2 expansion study in second-line metastatic colorectal cancer (2L mCRC). As presented at AACR (Free AACR Whitepaper) 2026, and based on an April 13, 2026 data cutoff, 15 patients had been enrolled and treated with ST316 in combination with standard of care (FOLFIRI and bevacizumab), with a confirmed objective response rate (ORR) of 47%, including seven confirmed partial responses, and a disease control rate (DCR) of 93%. These results compare favorably to historical outcomes for FOLFIRI and bevacizumab in 2L mCRC patients, which have demonstrated an 11% ORR. Responses were observed across multiple patient subgroups, including those with RAS-mutated and RAS wild-type tumors, liver metastases, and prior bevacizumab exposure. In the 23-patient Phase 1 monotherapy portion of the study, ST316 demonstrated a favorable safety and tolerability profile, as previously disclosed at AACR (Free AACR Whitepaper) 2026. These results provide clinical validation of β-catenin/BCL9 pathway antagonism in humans and support the rationale for evaluating ST316 in other β-catenin-driven diseases, including FAP, where the pathway is uniformly activated.

Familial adenomatous polyposis (FAP) is a rare inherited condition, characterized by the development of numerous adenomatous polyps in the colon and rectum, typically resulting from mutations in the APC gene. Without intervention, individuals with FAP face a near-certain lifetime risk of developing colorectal cancer. Current management strategies rely heavily on intensive surveillance and prophylactic surgery, underscoring the need for effective medical therapies that can reduce disease burden and delay or prevent surgical intervention. FAP affects an estimated 1 in 5,000 to 10,000 individuals in the United States, according to the National Organization for Rare Disorders, and there are currently no FDA-approved medical therapies for the condition.

About ST316
ST316 is Sapience Therapeutics’ first-in-class β-catenin antagonist designed to selectively inhibit the oncogenic activity of β-catenin through blockade of its interaction with BCL9, a critical transcriptional co-activator in the Wnt/β-catenin signaling pathway. This selective mechanism is designed to spare normal Wnt-dependent processes such as intestinal stem cell renewal and bone homeostasis, the mechanistic basis for the dose-limiting gastrointestinal and bone toxicities seen with broad Wnt pathway inhibitors. Consistent with this rationale, ST316 has not been associated with any gastrointestinal or bone-related adverse events leading to dose reduction, interruption, or discontinuation among the 38 patients treated to date in the Phase 1 monotherapy (n=23) and Phase 2 FOLFIRI and bevacizumab combination cohort of the study (n=15). Aberrant β-catenin signaling is a key driver of numerous cancers and pre-cancerous diseases, including familial adenomatous polyposis (FAP). ST316 is currently being evaluated in an ongoing Phase 2 dose expansion study in second-line metastatic colorectal cancer (2L mCRC) in combination with standard-of-care therapy. ST316 has received Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of FAP.

(Press release, Sapience Therapeutics, SEP 14, 2026, View Source [SID1234670835])

On September 14, 2026 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or "the Company", 6990.HK) reported that results from the phase III registrational study of its novel human epidermal growth factor receptor 2 (HER2)-targeted antibody–drug conjugate (ADC) trastuzumab botidotin (舒泰莱) in HER2-positive unresectable or metastatic breast cancer (BC) have been published in Journal of Clinical Oncology (JCO, impact factor (IF)=44.7). Professor Xichun Hu and Professor Hongxia Wang of Fudan University Shanghai Cancer Center, and Dr. Junyou Ge, Director of the National Engineering Research Center of Targeted Biologics act as the co-senior authors. Professor Jian Zhang of Fudan University Shanghai Cancer Center, Professor Quchang Ouyang of Hunan Cancer Hospital, Professor Qingyuan Zhang of Harbin Medical University Cancer Hospital, Professor Huihui Li of Cancer Hospital of Shandong First Medical University, and Professor Xu Wang of Tianjin Medical University Cancer Institute and Hospital act as the co-first authors. These findings had previously been selected as a Late-Breaking Abstract (LBA) and presented as an oral presentation at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress.

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This randomized, open-label, multicenter phase III study was designed to evaluate the efficacy and safety of trastuzumab botidotin monotherapy versus trastuzumab emtansine (T-DM1) in patients with HER2-positive unresectable or metastatic BC who had received prior trastuzumab and taxane-containing regimens. A total of 365 patients were randomized 1:1 to receive trastuzumab botidotin or T-DM1. The primary endpoint was progression-free survival (PFS) assessed by blinded independent central review (BICR), and secondary endpoints included overall survival (OS), objective response rate (ORR), and duration of response (DoR).

As of the data cutoff date of April 26, 2025, with a median follow-up of 14.9 months, efficacy results showed:

Median PFS was significantly prolonged in the trastuzumab botidotin group compared with the T-DM1 group (11.1 months vs. 4.4 months; hazard ratio (HR) = 0.39) (Figure A), meeting the primary endpoint of the study; consistent PFS benefit was observed across all prespecified subgroups (Figure B).

Trastuzumab botidotin group demonstrated deeper and more durable tumor responses compared with T-DM1 group, with an ORR of 76.9% vs. 53.0% and a median DoR of 12.2 months vs. 5.7 months (Figure C).

OS data were not mature in both groups, but an OS benefit trend was observed in trastuzumab botidotin group, demonstrating a 38% reduction in the risk of death (Figure D).
In terms of safety, patients in the trastuzumab botidotin group had a low incidence of interstitial lung disease (ILD), and the incidences of hematologic, hepatic, and gastrointestinal toxicities were notably lower than those in the T-DM1 group, along with lower rates of serious adverse events (SAEs) and treatment discontinuations. The most common treatment-related adverse events (TRAEs) in trastuzumab botidotin group were ocular events, which could be recovered or reversed after management with standardized strategies.

The publication of the phase III results for trastuzumab botidotin in Journal of Clinical Oncology marks a major international academic breakthrough for a domestically developed HER2 ADC backed by high-level clinical evidence. This is the first phase III trial in China for a HER2 ADC compared head-to-head with T-DM1 with positive results. The data showed that trastuzumab botidotin demonstrated improvements in key efficacy endpoints including PFS, ORR, and DoR, along with a favorable safety profile. Based on these positive results, trastuzumab botidotin has been approved by China’s National Medical Products Administration (NMPA) for the treatment of second-line or later HER2-positive BC, becoming the first domestically developed HER2 ADC approved for this indication in China and providing a new treatment option for patients with HER2-positive advanced breast cancer.

About Trastuzumab botidotin(舒泰莱)

Trastuzumab botidotin is a differentiated HER2 ADC to treat advanced HER2+ solid tumors. As an innovative HER2 ADC developed by the Company, it conjugates a novel, monomethyl auristatin F (MMAF) derivative (a highly cytotoxic tubulin inhibitor, Duo-5) via a stable, enzyme-cleavable linker to a HER2 monoclonal antibody with a DAR of 2. Trastuzumab botidotin specifically binds to HER2 on the surface of tumor cells and is internalized by tumor cells, releasing the toxin molecule Duo-5 inside the cell. Duo-5 induces tumor cell cycle arrest in the G2/M phase, leading to tumor cell apoptosis. After targeting HER2, trastuzumab botidotin can also inhibit the HER2 signaling pathway; it has antibody-dependent cell-mediated cytotoxicity (ADCC) activity.

Based on the results of a multi-center, randomized, open-label, controlled Phase 3 KL166-III-06 study, trastuzumab botidotin was approved for marketing by the NMPA for adult patients with unresectable or metastatic HER2 positive BC who have received one or more prior anti-HER2 therapy. At a pre-specified interim analysis, trastuzumab botidotin monotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of PFS as assessed by the BICR compared with T-DM1; the beneficial trend for OS of trastuzumab botidotin was also observed.

Currently, the Company has initiated an open, multi-center Phase 2 clinical study of trastuzumab botidotin in the treatment of HER2+ unresectable or metastatic BC that previously received a topoisomerase inhibitor payload ADC.

(Press release, Kelun, SEP 14, 2026, View Source [SID1234670834])

On September 14, 2026 Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology, reported the pricing of an underwritten offering of 9,079,000 shares of its common stock at a price of $22.03 per share and, in lieu of shares of common stock to certain investors, pre-funded warrants to purchase 9,078,529 shares of common stock at a purchase price of $22.029 per share, which equals the offering price per share of the common stock less the $0.001 exercise price per share of each pre-funded warrant. All of the shares of common stock and pre-funded warrants in the offering are being sold by Tyra. The gross proceeds to Tyra from the offering, before deducting the underwriting discounts and commissions and other offering expenses, are expected to be approximately $400.0 million. The offering is expected to close on September 15, 2026, subject to the satisfaction of customary closing conditions.

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TYRA intends to use the net proceeds from this offering, together with its existing cash, cash equivalents and marketable securities, to advance its "dabogratinib 3×3" development strategy in low-grade upper tract urothelial carcinoma (LG-UTUC), intermediate-risk non-muscle invasive bladder cancer (IR NMIBC) and achondroplasia (ACH), as well as to support its preclinical and drug discovery programs, working capital and other general corporate purposes.

The offering was led by RA Capital Management, with participation by new and existing institutional investors, including Invus, Commodore Capital, BVF Partners, Janus Henderson Investors, Trails Edge Capital Partners, Integral Health Asset Management, TCGX, StemPoint Capital LP and multiple large investment management firms.

Jefferies, Guggenheim Securities, Cantor, Barclays and William Blair are acting as joint book-running managers for the offering. Wedbush PacGrow, Raymond James and Oppenheimer & Co. are acting as lead managers.

The shares of common stock and pre-funded warrants described above are being offered by Tyra pursuant to a shelf registration statement on Form S-3, including a base prospectus, filed with the Securities and Exchange Commission (SEC) and that became automatically effective on September 14, 2026. A prospectus supplement and accompanying prospectus relating to this offering will be filed with the SEC. When available, copies of the prospectus supplement and the accompanying prospectus relating to this offering may be obtained from: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, or by telephone at (877) 821-7388, or by e-mail at [email protected]; Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, by telephone at (212) 518-9544, or by email at [email protected]; Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, New York, NY 10022, or by email at [email protected]; or Barclays Capital Inc. c/o Broadridge Financial Solutions 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at 1-888-603-5847 or by email at [email protected]. Electronic copies of the prospectus supplement and accompanying prospectus will also be available on the website of the SEC at View Source

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

(Press release, Tyra Biosciences, SEP 14, 2026, View Source [SID1234670833])