Janssen Pharmaceuticals has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for approval of amivantamab for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease progressed on or following platinum-based chemotherapy.
In addition to the application, Janssen also announced an expanded access program (EAP) for patients in the US who may be eligible to access amivantamab during the BLA review process.
Amivantamab is an investigational EGFR and mesenchymal epithelial transition factor (MET) bispecific antibody with immune cell-directing activity to target tumors with activating and resistant EGFR and MET mutations. This is the first regulatory submission for the treatment of NSCLC with EGRF exon 20 insertion mutations. In March 2020, amivantamab received the Breakthrough Therapy Designation from the FDA for this patient population.
“This submission marks an important step forward in our drive toward evolving the treatment landscape for patients with NSCLC who have EGFR exon 20 insertion mutations and for whom there are no FDA-approved targeted treatment options,” said Peter Lebowitz, MD, PhD, Global Therapeutic Area Head, Oncology, at Janssen Research & Development, in a press release.
BREAKING: A Biologics License Application was submitted to the FDA seeking approval of amivantamab as treatment of patients with metastatic non–small cell lung cancer harboring EGFR exon 20 insertion mutations…https://t.co/HM23nISO9C #lungcancer #EGFR
— Targeted Oncology (@TargetedOnc) December 3, 2020
The submission is supported by data from the monotherapy arm of the phase I, open-label CHRYSALIS study, which evaluated amivantamab in combination with lazertinib, a third-generation EGFR tyrosine kinase inhibitor (TKI), in adults with advanced NSCLC. In 20 treatment-naïve patients, the combination of amivantamab and lazertinib achieved a 100% overall response rate (ORR; 95% CI 83-100), and a 36% ORR among 45 osimertinib-relapsed, chemotherapy-naïve patients (95% CI 22-51). Early data from this trial was presented at the American Society of Clinical Oncology (ASCO) 2020 Virtual Scientific Program (abstract #9512).
“Despite treatment advancements, lung cancer remains the leading cause of cancer deaths globally, and there are opportunities to improve treatment options for patients with non-small cell lung cancer with genetic factors such as EGFR mutations,” said lead investigator Byoung Chul Cho, MD, PhD, Yonsei Cancer Center in Seoul, South Korea, in a press release. “We are encouraged by these results that suggest amivantamab in combination with lazertinib may be a promising option in this specific disease cohort where a high unmet need remains for more targeted treatment options.”
— Dr. Sonia Rao (@Thesrao) December 3, 2020