JnJ gets USFDA nod for Rybrevant plus standard of care chemotherapy for lung cancer treatment
Raritan: Johnson & Johnson has announced that the U.S. Food and Drug Administration (FDA) has approved RYBREVANT (amivantamab-vmjw) in combination with standard of care chemotherapy (carboplatin and pemetrexed) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor (TKI).
“RYBREVANT plus chemotherapy may address the most common mechanisms of treatment resistance to third generation EGFR TKIs, such as osimertinib, in the first line,” said Martin Dietrich*, M.D., Ph.D., Oncologist, Cancer Care Centers of Brevard. “This multitargeted combination extended progression-free survival and improved overall response compared to chemotherapy alone, offering an important and effective new second-line option for patients.”
The five-year survival rate is less than 20 percent for all people with advanced EGFR-mutated NSCLC. Acquired resistance mechanisms after TKI monotherapy are diverse and polyclonal, making targeted therapy at progression more difficult, thus limiting the efficacy of targeted therapies at progression. Adding immunotherapy to chemotherapy has also failed to demonstrate clinically meaningful improvements.
“The progression-free survival benefits seen in the MARIPOSA-2 study are exciting,” said Andrea Ferris**, President and CEO, LUNGevity Foundation. “It is good to see new therapeutic options like the combination of RYBREVANT and chemotherapy helping to address unmet needs impacting individuals with EGFR-mutated lung cancer, with the potential for positive change, which gives hope to more patients and their families.”
The FDA approval is based on results from the Phase 3 MARIPOSA-2 (NCT04988295) study evaluating the efficacy and safety of RYBREVANT in combination with chemotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR ex19del or L858R substitution mutations after disease progression on or after osimertinib. Results showed RYBREVANT plus chemotherapy reduced the risk of disease progression or death (progression-free survival [PFS]) by 52 percent vs. chemotherapy alone, the study’s primary endpoint. The median PFS for patients receiving RYBREVANT plus chemotherapy was 6.3 months, compared to 4.2 months for chemotherapy alone. Additionally, RYBREVANT plus chemotherapy showed a confirmed overall response rate (ORR) of 53 percent compared to 29 percent with chemotherapy alone.
Amivantamab-vmjw (RYBREVANT) in combination with chemotherapy is the only National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines) Category 1 treatment option for patients with EGFR-mutated NSCLC progressing on osimertinib who are symptomatic with multiple lesions.
“This milestone reinforces RYBREVANT as an important treatment option for patients with EGFR-mutated NSCLC who continue to face high unmet needs after disease progression on or after TKI therapy,” said Kiran Patel, M.D., Vice President, Clinical Development, Solid Tumors, Johnson & Johnson Innovative Medicine. “Patients need and deserve effective, targeted approaches across all lines of therapy. With RYBREVANT-based regimens, we are bringing potential new standards of care to the nearly 30,000 patients diagnosed with EGFR-mutated NSCLC in the United States each year.”
The safety profile of RYBREVANT in combination with chemotherapy was consistent with the established profiles of the individual treatments. Permanent discontinuation of RYBREVANT due to adverse reactions occurred in 11 percent of patients.
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