Rybrevant receives FDA accelerated approval as the first targeted treatment for patients with non-small cell lung cancer with EGFR Exon 20 insertion mutations.- Janssen + Genmab A/S

Genmab A/S announced that the FDA has approved Janssen’s Rybrevant (amivantamab-vmjw), a fully human bispecific antibody, for the treatment of adult patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) Exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy. In July 2012, Genmab entered into a collaboration with Janssen to create and develop bispecific antibodies using Genmab’s DuoBody technology platform. This is the first regulatory approval for a product that was created using Genmab’s proprietary DuoBody technology platform. Under the agreement with Janssen, Genmab will receive royalties on net sales of Rybrevant. Rybrevant is a fully-human bispecific antibody directed against EGFR and MET receptors. Rybrevant binds extracellularly (outside of the cell) inhibiting tumor growth and leading to tumor cell death. The accelerated FDA approval is based on positive results from the Phase 1 CHRYSALIS study, a multicenter, open-label, clinical study evaluating Rybrevant as a monotherapy in patients enrolled in the prior platinum containing chemotherapy cohort . Initial results from the CHRYSALIS EGFR exon 20 insertion mutation population, which supported the BTD, were presented at the American Society of Clinical Oncology 2020 Virtual Scientific Program, and updated results were presented at the IASLC WCLC 2020. Lung cancer : is the leading cause of cancer death among both men and women, accounting for almost 25 percent of all cancer deaths.Currently available targeted treatments, like EGFR tyrosine kinase inhibitors (TKI) are generally insensitive in treating NSCLC driven by EGFR exon 20 insertion mutations and are not FDA-approved for these patients. In addition, NSCLC driven by this mutation carries a worse prognosis and shorter survival rates compared with lung cancer driven by more common EGFR mutations, such as exon 19 deletions and L858R substitutions. Patients newly diagnosed with metastatic NSCLC with EGFR exon 20 insertion mutations have a real-world median overall survival (OS) of 16.2 months (95 percent confidence interval [CI], 11.0 – 19.4), which is lower than patients with EGFR exon 19 deletions/L858R mutations, who have a real-world median OS of 25.5 months (95 percent CI, 24.5 – 27.0).