FDA Approval Insights: Amivantamab and Mobocertinib in EGFR Exon 20 Insertion+ NSCLC

Welcome to OncLive On Air^®! I’m your host today, Jessica Hergert.

OncLive On Air^® is a podcast from OncLive^®, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive^® covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.

In today’s episode, sponsored by Janssen, we had the pleasure of speaking with Sandip P. Patel, MD, a medical oncologist and an associate professor of medicine at the University of California San Diego School of Medicine, to discuss the FDA approvals of amivantamab-vmjw (Rybrevant) and mobocertinib (Exkivity) for patients with non–small cell lung cancer (NSCLC) who harbor EGFR exon 20 insertion mutations.

On May 21, 2021, the FDA approved amivantamab as the first treatment for adult patients with NSCLC who harbor EGFR exon 20 insertion mutations.

The regulatory agency also gave the green light to Guardant360 CDx, developed by Guardant Health Inc., for use as a companion diagnostic for the drug.

Amivantamab has been examined in a study that enrolled 81 patients with NSCLC and EGFR exon 20 insertion mutations whose disease had progressed either on, or after, platinum-based chemotherapy. Results indicated the agent elicited an overall response rate (ORR) of 40% in this population, with a median duration of response (DOR) of 11.1 months. Notably, 63% of patients experienced a DOR that persisted for 6 months or longer.

On September 15, 2021, the FDA granted an accelerated approval to mobocertinib 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.

The agency also gave the green light to the Thermo Fisher Scientific’s Oncomine Dx Target Test as a next-generation sequencing companion diagnostic for the agent to identify patients with NSCLC harboring EGFR exon 20 insertions.

The regulatory decision was based on results from a phase 1/2 trial (NCT02716116) on a cohort of 114 patients with EGFR exon 20 insertion–positive NSCLC who received prior platinum-based therapy and received the agent at a dose of 160 mg.

Results showed that mobocertinib elicited a confirmed ORR of 28% (95% CI, 20%-37%) per independent review committee assessment, with a median DOR of 17.5 months (95% CI, 7.4-20.3). Moreover, the median progression-free survival achieved with mobocertinib in this cohort was 7.3 months (95% CI, 5.5-9.2), and the median overall survival was 24.0 months (95% CI, 14.6-28.8).

In our exclusive interview, Patel discussed the role of biomarker testing in lung cancer, the FDA approvals of amivantamab and mobocertinib in EGFR exon 20 insertion–positive NSCLC, and future research directions in this subset of lung cancer.

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