Keytruda combo scores FDA nod in first-line cervical cancer

Ref: Business Wire;FDA

The FDA on Wednesday approved combining Merck & Co.'s anti-PD-1 therapy Keytruda (pembrolizumab) plus chemotherapy, with or without Roche's Avastin (bevacizumab), for patients with persistent, recurrent or metastatic cervical cancer whose tumours express PD-L1 with a combined positive score (CPS) ≥1. Roy Baynes, chief medical officer at Merck Research Laboratories, said the decision "brings an important new first-line treatment option" for this patient population.

The approval is based on the Phase III KEYNOTE-826 trial, which showed that adding Keytruda to chemotherapy, regardless of Avastin use, extended survival in first-line cervical cancer by eight months, compared to standard treatment, according to updated findings unveiled at the European Society for Medical Oncology (ESMO) congress last month. The hazard ratios for overall survival and progression-free survival, the trial's dual primary endpoints, were 0.64 and 0.62, respectively. Baynes called the 36% reduction in the risk of death "compelling."

The combination was also associated with an overall response rate (ORR) of 68%, compared to an ORR of 50% for chemotherapy, with or without Avastin.

Monotherapy indication switched to full approval

In addition, Merck said the FDA converted the accelerated approval of Keytruda monotherapy, granted in 2018 in second-line cervical cancer patients whose tumours express PD-L1 with a CPS ≥1, to a regular approval based on confirmatory data from KEYNOTE-826.

The news comes a few weeks after the FDA granted an accelerated approval to Seagen and Genmab's antibody-drug conjugate Tivdak (tisotumab vedotin-tftv) as monotherapy to treat adults with recurrent or metastatic cervical cancer who have experienced disease progression on or after chemotherapy. For more on that and potential competitor impact, see ViewPoints: Near-term secured, longer-term TBD for Tivdak.