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Shennon Biotechnologies Raises $12M in Financing, Appoints Cyril Konto, M.D., as Chief Executive Officer and Unveils Precision Immunotherapy Pipeline

On September 14, 2026 Shennon Biotechnologies ("ShennonBio"), a biotechnology company developing precision immunotherapies for cancer, reported that it has raised $12M in financing from Future Ventures, NextGen Venture Partners, Samos Investments, Atypical Ventures and Saras Capital, with continued support from existing investors DCVC, Foundation Capital, and AV8 Ventures. The company has raised $25M to date.

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In addition to the funding, the Company has appointed biotechnology industry veteran Cyril Konto, M.D. as Chief Executive Officer. Founder and current CEO Li Sun, Ph.D., will transition to President and Chief Technology Officer, continuing to lead the Company’s scientific strategy, technology development and pipeline innovation.

The new financing will support continued development of ShennonBio’s integrated technology platform and advancement of its emerging oncology pipeline that currently includes three T-cell engager (TCE) programs in small cell lung cancer, ovarian cancer and hepatocellular carcinoma.

Since its founding in 2021, ShennonBio has built a proprietary technology engine spanning target discovery, ultra-high-throughput functional screening, computational binder prediction and optimization, and AI-enabled safety assessment. The Company has also established approximately 6,000 square feet of laboratory space in San Francisco near UCSF Mission Bay and assembled proprietary datasets with fresh tumor samples from strong partnerships with hospitals and academic institutions.

"ShennonBio was founded to address fundamental challenges that have limited the development of precision immunotherapies, from identifying differentiated targets and highly functional therapeutic binders to predicting potential safety risks before candidates reach the clinic," said Li Sun, Ph.D., Founder, President and Chief Technology Officer, ShennonBio. "We have built an integrated technology platform, generated proprietary human datasets and begun translating those capabilities into a pipeline of precision immunotherapies. With $25 million raised to date, and Cyril joining as CEO, we are entering an important new stage for ShennonBio as we advance our first TCE programs toward the clinic."

Building an Integrated Platform for Precision Immunotherapy

ShennonBio is developing both antibody-based T-cell engagers (Ab-TCEs), which can address targets expressed on the surface of tumor cells, and TCR-based T-cell engagers (TCR-TCEs), which can potentially access intracellular cancer targets presented through HLA. This dual approach is designed to substantially expand the universe of cancer biology that can potentially be addressed through T-cell engagers.

The Company’s integrated platform combines four proprietary capabilities:

PINTRA, which uses proprietary human tumor datasets and advanced computational approaches to identify differentiated surface and intracellular therapeutic targets;
TCELERATOR, an ultra-high-throughput functional screening platform capable of evaluating more than 10 million single-cell interactions concurrently and millions of therapeutic candidates;
AFFINIS, a computational platform for predicting, designing and optimizing antibody binders and TCR; and
SERIS, an AI-enabled safety platform designed to identify potential off-target cross-reactivity earlier in therapeutic development.
Together, these technologies create an integrated discovery and development engine spanning target identification, functional screening, therapeutic optimization and safety assessment.

A central component of ShennonBio’s approach is its growing proprietary human dataset. The Company has assembled data encompassing >10,000 tumor samples, >11 million single cells and a substantial collection of TCR sequences. ShennonBio continues to expand these datasets through relationships involving more than 15 institutions and across multiple cancer types and other diseases.

Advancing a Diversified Oncology Pipeline

ShennonBio has translated its platform into three initial oncology programs spanning both antibody- and TCR-based T-cell engagers.

SBT-121 is a dual-targeting trispecific Ab-TCE being developed for small cell lung cancer.

SBT-201 is an Ab-TCE being developed for ovarian cancer.

SBT-425 is a TCR-TCE being developed for hepatocellular carcinoma.

Together, the programs reflect ShennonBio’s strategy of combining established T-cell engager biology with its proprietary discovery and screening capabilities to pursue differentiated therapeutic opportunities across solid tumors.

As ShennonBio advances from platform development toward development-stage execution, the Company has appointed Cyril Konto, M.D., as Chief Executive Officer. Dr. Sun, ShennonBio’s founder and current CEO, will transition to President and Chief Technology Officer, and will remain deeply committed to the Company, leading scientific strategy, technology development and pipeline innovation.

Dr. Konto brings more than 20 years of experience in oncology drug development, company building and strategic transactions. Most recently, he served as President and Chief Executive Officer of Ichnos Glenmark Innovation (IGI), where he led a strategic and operational transformation of the organization, focused its portfolio on oncology and built its multispecifics franchise.

During his tenure, IGI completed three external partnerships, including an agreement with AbbVie for a Phase 1 trispecific T-cell engager that included $700 million upfront and up to $1.9 billion in total potential value plus royalties. He previously held senior oncology development leadership roles at Allogene Therapeutics, Pfizer and Bristol Myers Squibb.

"ShennonBio has spent the last several years building a differentiated foundation spanning proprietary human data, target discovery, functional screening, therapeutic design and safety prediction," said Dr. Konto. "What attracted me to the Company is the opportunity to translate those capabilities into a new generation of precision immunotherapies. I look forward to working closely with Li and the team to advance our pipeline toward the clinic, establish strategic partnerships and build ShennonBio for its next stage of growth."

Over the next two years, ShennonBio plans to advance a development candidate toward IND filing and Phase 1 clinical development, pursue licensing opportunities for selected therapeutic programs and explore partnerships around its platform capabilities, including binder prediction and generation, clinical toxicity prediction and its proprietary datasets.

(Press release, Shennon Biotechnologies, SEP 14, 2026, View Source [SID1234670842])

Vyriad Begins Phase 1 Clinical Trial for Lead In Vivo CAR T Cell Therapy VV169 Following FDA Acceptance of IND Application

On September 14, 2026 Vyriad, Inc., a clinical-stage biotechnology company developing targeted genetic therapies for cancer and other serious diseases, reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to initiate a clinical trial of VV169, an off-the-shelf, in vivo CAR T cell therapy targeting BCMA in patients with relapsed/refractory multiple myeloma. The Phase 1 trial is now open for enrollment at Mayo Clinic.

"VV169 is designed to create CAR-T cells directly inside the body, offering a new way of delivering this powerful therapeutic approach to patients with multiple myeloma. The Phase 1 clinical trial for VV169 being open for enrollment is a significant milestone for Vyriad and we are proud to reach it alongside Dr. Yi Lin and her team at Mayo Clinic," said Luke Russell, Ph.D., MBA, President of Vyriad. "This reflects years of sustained effort from investigators, study staff, and the R&D and manufacturing teams here in Rochester. We are grateful to everyone who made it happen, and to the patients who choose to take part."

VV169 was developed using Vyriad’s proprietary in vivo lentiviral platform centered on blinded and retargeted VSV-G pseudotyping. To enable direct in vivo delivery, VV169 utilizes the targeted lentiviral vector to deliver a potent anti-BCMA CAR payload. Upon intravenous administration, the vehicle specifically targets and transduces T cells, enabling rapid generation of functional CAR T cells. This targeted approach results in highly specific payload expression and minimizes the risk of infusional toxicities.

"For patients with aggressive multiple myeloma, waiting weeks for a therapy to be manufactured can be a significant barrier," said Chief Scientific Officer Stephen Russell, M.D., Ph.D. "VV169 is designed to change that by creating CAR T cells directly inside the body, thereby making this off-the-shelf approach to CAR T more accessible for patients. We look forward to evaluating the potential of this program in the clinic."

The Phase 1 trial will evaluate the safety and initial efficacy signals of VV169 in up to 40 patients with relapsed/refractory multiple myeloma. The trial, conducted at Mayo Clinic by principal investigator Yi Lin, M.D., Ph.D., head of the center’s in vivo CAR T program, will have key primary objectives to assess overall safety, identify dose-limiting toxicities, and determine the recommended Phase 2 dose. The secondary objective will focus on assessing preliminary efficacy signals of VV169 and evaluating in vivo CAR T cell expansion and persistence.

For more information, including trial details and eligibility criteria, please visit the study page on clinicaltrials.gov (NCT07802717).

(Press release, Vyriad, SEP 14, 2026, View Source [SID1234670841])

MaaT Pharma Receives Negative CHMP Trend Vote for MaaT013 (Xervyteg®) Following Re-Examination for its Conditional Marketing Authorization Application in Europe

On September 14, 2026 MaaT Pharma (EURONEXT: MAAT – the "Company"), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem Therapies (MET) dedicated to enhancing survival for patients with cancer through immune modulation, reported that it has been informed by the CHMP of the European Medicines Agency (EMA) of a "negative trend" opinion following the Oral Explanation, as part of the re-examination procedure of its conditional Marketing Authorization Application (MAA) for MaaT013 (Xervyteg) for the treatment of aGvHD, following yesterday’s CHMP oral explanation.

"We are deeply disappointed by this outcome. Patients suffering from gastrointestinal-aGvHD continue to face a life-threatening condition with significant unmet medical need and limited treatment options," said Hervé Affagard, Chief Executive Officer and co-founder of MaaT Pharma. "Together with the hematology community, we remain committed to these patients and will evaluate all available options to make this potentially important treatment accessible to patients worldwide."

Based on the feedback received post Oral Explanation, the CHMP maintained its view that the available clinical data package, primarily in the absence of a randomized control trial, does not allow sufficient characterization of the benefit/risk of MaaT013 (Xervyteg).

The Company will provide additional details following the formal CHMP opinion, which is expected to be communicated on September 18, 2026. The Company will assess the implications of the decision and evaluate all available options and will provide an update to the market as appropriate.

(Press release, MaaT Pharma, SEP 14, 2026, View Source [SID1234670840])

FDA APPROVES REDUCED MONITORING TIME FOR FIRST TWO DOSES OF IMDELLTRA

On September 14, 2026 Amgen (NASDAQ:AMGN) reported that the U.S. Food and Drug Administration (FDA) approved an update to the IMDELLTRA (tarlatamab-dlle) Prescribing Information that substantially reduces the recommended monitoring time for the first two doses of treatment in an appropriate healthcare setting.

This approval means that patients receiving IMDELLTRA should now be monitored for 6 to 8 hours from the start of their first two infusions, compared with the previously recommended 22 to 24 hours. Patients will also receive a follow-up assessment, including vital signs, the day after each of these first two doses.

For people living with extensive-stage small cell lung cancer (ES-SCLC), the change could mean substantially less time spent in a healthcare setting during the initial treatment period. The updated requirement may also reduce treatment complexity for community oncology practices, where an estimated 80% to 85% of U.S. cancer patients receive care.1

"People being treated for small cell lung cancer are already navigating an aggressive and difficult-to-treat disease, and the time required to receive and monitor treatment can add to that burden for both patients and care centers," said Jay Bradner, M.D., executive vice president, Research and Development, Artificial Intelligence and Data at Amgen. "This approval is an important step in simplifying care for people living with and treating ES-SCLC. Reducing monitoring to 6-8 hours for the initial doses may help address practical barriers associated with administering IMDELLTRA and enable more patients to receive care closer to home. We continue to work closely with the healthcare community to ensure appropriate educational support for navigating IMDELLTRA treatment is available to providers, patients and care partners."

"In community oncology, we care for patients where they live, and for people living with small cell lung cancer, that matters," said David M. Waterhouse, MD, MPH, FASCO, medical oncologist/hematologist at Oncology Hematology Care in Cincinnati, OH. "These patients are often very sick, and traveling long distances or spending extended time in a healthcare setting can be difficult for them and their families. Reducing the required monitoring period may make IMDELLTRA more feasible to administer in community practices, helping more patients receive treatment in their local care network and spend less time away from their support systems."

ES-SCLC is an aggressive form of lung cancer in which most patients experience disease progression following first-line treatment.2 The scope of the label update was limited to the first two doses, which now recommends only 6 to 8 hours of monitoring from the start of infusion in an appropriate healthcare setting. Beyond the update to the first two doses and the addition of a patient assessment following those initial doses, the monitoring and supportive care recommendations remain unchanged: 6-8 hours of monitoring following the third dose (Cycle 1 Day 15) and throughout Cycle 2, decreasing to 3-4 hours for Cycles 3-4 and 2 hours for Cycle 5 and subsequent doses. It is recommended that patients remain within 1 hour of an appropriate healthcare setting for a total of 48 hours from the start of the infusion with IMDELLTRA following Cycle 1 Day 1 and Cycle 1 Day 8 doses, accompanied by a caregiver. Patients will also receive a follow-up assessment, including vital signs, the day after each of these first two doses on Cycle 1, Days 2 and 9.

The updated monitoring requirements represent an important evolution in the administration of IMDELLTRA and reinforce Amgen’s commitment to advancing treatments while addressing the real-world needs of people living with cancer.

Amgen recently announced landmark positive topline overall survival data from the Phase 3 DeLLphi-305 study in first-line ES-SCLC. Reduced post-infusion monitoring timing is being evaluated in several ongoing studies across indications and lines of therapy which will continue to inform the potential to further reduce monitoring approaches in the future.

About Small Cell Lung Cancer (SCLC)
SCLC is one of the most aggressive and devastating forms of solid tumor cancer. Each year, SCLC accounts for approximately 13-15% of more than 2.6 million cases of lung cancer diagnosed worldwide.2-4 Despite initial high response rates to first-line platinum-based chemotherapy, most patients quickly relapse within months and require subsequent treatment options.2

About IMDELLTRA (tarlatamab-dlle)
IMDELLTRA is a first-in-class targeted immunotherapy engineered by Amgen researchers to bind to both DLL3 on tumor cells and CD3 on T cells, thereby activating T cells to kill DLL3-expressing SCLC cells. This results in the formation of a cytolytic synapse with lysis of the cancer cell.5,6 DLL3 is a protein that is expressed on the surface of SCLC cells in ~85-96% of patients with SCLC, but is minimally expressed on healthy cells, making it an exciting target.7,8

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

IMPORTANT SAFETY INFORMATION

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

Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving IMDELLTRA. Initiate IMDELLTRA using the step-up dosing schedule to reduce the incidence and severity of CRS. Withhold IMDELLTRA until CRS resolves or permanently discontinue based on severity.
Neurologic toxicity and immune effector cell-associated neurotoxicity syndrome (ICANS), including life-threatening or fatal reactions, can occur in patients receiving IMDELLTRA. Monitor patients for signs and symptoms of neurologic toxicity, including ICANS, during treatment and treat promptly. Withhold IMDELLTRA until ICANS resolves or permanently discontinue based on severity.
WARNINGS AND PRECAUTIONS

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Administer IMDELLTRA as an intravenous infusion over 1 hour.
Administer IMDELLTRA according to the step-up dose in the IMDELLTRA PI (Table 1) to reduce the incidence and severity of CRS.
Evaluate complete blood count, liver enzymes and bilirubin prior to administration of all doses of IMDELLTRA up through Cycle 5 Day 15 and then prior to administration of IMDELLTRA on Day 1 of each cycle starting with Cycle 6. More frequent evaluation may be necessary if clinically indicated.
For Cycle 1, administer recommended concomitant medications before and after Cycle 1 Day 1 and Cycle 1 Day 8 IMDELLTRA infusions to reduce the risk of CRS reactions as described in the PI (Table 3).
IMDELLTRA should only be administered by a qualified healthcare professional with appropriate medical support to manage severe reactions such as CRS and neurologic toxicity including ICANS.
Due to the risk of CRS and neurologic toxicity, including ICANS, monitor patients from the start of the IMDELLTRA infusion for 6 to 8 hours following Cycle 1 Day 1 and Cycle 1 Day 8 in an appropriate healthcare setting.
Perform patient assessment including vital signs check on Cycle 1 Days 2 and 9.
Recommend that patients remain within 1 hour of an appropriate healthcare setting for a total of 48 hours from the start of the infusion with IMDELLTRA following Cycle 1 Day 1 and Cycle 1 Day 8 doses, accompanied by a caregiver.
Inform both the patient and the caregiver on the signs and symptoms of CRS and ICANS prior to discharge.
Ensure patients are well hydrated prior to administration of IMDELLTRA.

(Press release, Amgen, SEP 14, 2026, View Source [SID1234670839])

RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) plus LAZCLUZE® (lazertinib) with prophylactic strategies shows low rates of treatment-related events at WCLC 2026

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

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])