FDA accepts Merck & Co.'s filing for Keytruda, chemotherapy combination in lung cancer

The FDA accepted a filing from Merck & Co. seeking approval of the anti-PD-1 therapy Keytruda (pembrolizumab) plus chemotherapy for the first-line treatment of patients with metastatic or advanced non-squamous non-small-cell lung cancer (NSCLC) regardless of PD-L1 expression and with no EGFR or ALK genomic tumour aberrations, the company announced. The agency granted the application priority review with a target action date of May 10.

Roger Dansey, therapeutic area head for oncology late-stage development at Merck Research Laboratories, remarked "if approved, this could be the first regimen combining chemotherapy with an immuno-oncology agent for patients with advanced non-small cell lung cancer." For related analysis, see JP Morgan 2017: Stealing their thunder? – Merck & Co. does it again.

According to Merck, the application, which seeks approval of Keytruda in combination with pemetrexed and carboplatin, is based on certain data from the KEYNOTE-021 study. The company noted that Part 2, Cohort G of the trial included 123 previously untreated patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumour aberrations and regardless of PD-L1 expression.

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Despite announcing results from the KEYNOTE-021 study in October, many analysts had expected that Merck would wait for results from a larger Phase III study before seeking approval. "This comes as an important surprise because if FDA approves the application, Merck would suddenly be catapulted ahead of all other (immunotherapy) competitors who are also pursuing competing combination regimens of their own," commented Bernstein analyst Tim Anderson. However, Jefferies analyst Jeffrey Holford, who agreed the early move was positive for Merck, cautioned that an approval was "high risk" given several weaknesses in the Phase II study.

Other companies expecting to report data from immunotherapy combinations this year include AstraZeneca in the first half of 2017 from a study of the PD-L1 inhibitor durvalumab and the CTLA-4 monoclonal antibody tremelimumab. Meanwhile, Bristol-Myers Squibb and Roche are also expected to release combination data during 2017.

Analysts at Evercore ISI estimate that the market for first-line NSCLC for all patients could reach $14 billion. "While Merck is unlikely to durably penetrate this entire population, especially with multiple competing regimens on the horizon, an approval in May would give them a significant first-mover advantage," noted Evercore analyst John Scotti.

Keytruda is currently authorised in the US for the first-line treatment of patients with metastatic NSCLC whose tumours have high PD-L1 expression, with no EGFR or ALK genomic tumour aberrations, as well as for the treatment of patients with metastatic NSCLC whose tumours express PD-L1, with disease progression on or after platinum-containing chemotherapy.

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