Johnson & Johnson (J&J) announced that its cancer drug Rybrevant (amivantamab-vmjw) in combination with chemotherapy consistent benefit in patients with a type of lung cancer.
The announcement is based on the updated results from the Phase 3 MARIPOSA-2 study.
In the study, Rybrevant plus chemotherapy showed post-progression outcomes in adults with non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations.
The data also showed a favourable trend toward improved overall survival (OS) compared to chemotherapy alone.
In the Phase 3 study, Rybrevant plus chemotherapy showed a safety profile that was consistent with the established profiles of the individual treatments.
Last month, the European Commission (EC) approved Rybrevant plus chemotherapy for the treatment of patients with previously treated NSCLC with common EGFR mutations.
Johnson & Johnson Innovative Medicine vice president, lung cancer disease area stronghold leader Joshua Bauml said: “We are pleased to see that Rybrevant plus chemotherapy continues to show improved survival outcomes after a year and a half of follow-up, providing real benefits to patients with few other options.
“These results underscore the potential of this combination regimen to make a meaningful difference for patients, and we anticipate continued improvement as we move toward the final analysis.”
In a separate development, J&J announced that its Rybrevant, combined with chemotherapy, showed promising antitumor activity in patients with a type of metastatic colorectal cancer (mCRC).
The US drugmaker’s announcement is based on new data from Phase 1b/2 OrigAMI-1 study.
Rybrevant plus chemotherapy (mFOLFOX6 [FOLFOX] or FOLFIRI) showed rapid and durable antitumor activity in patients with mCRC who have not received prior anti-EGFR therapy.
In the study, a total of 43 patients received Rybrevant, either with FOLFOX (20 patients) or FOLFIRI (23 patients).
The patients receiving Rybrevant plus chemotherapy were either in their first or second line of treatment for mCRC and had not been treated with specific anti-EGFR therapies.
They achieved an overall response rate (ORR) of 49%, a median duration of response of 7.4 months and a median progression-free survival of 7.5 months.
Also, Rybrevant plus Folfox/Folfiri showed a safety profile that was manageable and consistent with each of the individual components, without any additive toxicity, with no new safety signals.
The most frequent treatment-emergent adverse events include neutropenia, rash, stomatitis, infusion-related reactions, and diarrhoea.
Johnson & Johnson Innovative Medicine solid tumours clinical development vice president Kiran Patel said: “Confirmation that Rybrevant has activity beyond lung cancer, given its unique multi-targeted approach in inhibiting EGFR and MET, is a potentially important step forward for patients with EGFR inhibitor-naïve metastatic colorectal cancer.
“Colorectal cancer is the third most common cancer globally, representing about 10 per cent of all cancer cases and the second leading cause of cancer-related deaths.
“Our commitment to advancing cancer care drives us to evaluate every possibility to improve patient outcomes, and these findings highlight the potential of Rybrevant to help even more patients with cancer.”
