Summary
- Merck Announced FDA approval for Keytruda as a third-line therapy for patients with SCLC.
- SCLC accounts for about 10% to 15% of the entire lung cancer market.
- A competing drug for Keytruda in the third-line SCLC space is Opdivo, which was approved back in August of 2018.
- Merck is also looking to challenge Roche with its drug Tecentriq in front-line extensive-stage SCLC, data from KEYNOTE-604 will determine competitiveness.
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Merck (MRK) announced that it had received FDA approval for treating patients with small cell lung cancer (SCLC) using its anti-PD-1 inhibitor Keytruda. This win sets up Merck to compete against Bristol-Myers Squibb(BMY), which had already received approval for a third-line therapy treating SCLC back in August of 2018. This will allow Merck to expand its reach for Keytruda, which continues to dominate the lung cancer space. Not only that, but total sales of Keytruda are still above those of Opdivo.
FDA Approval Sets Up A Sizeable Niche Market Opportunity
The FDA specifically approved Keytruda for the treatment of patients with metastatic SCLC who have progressed on or after platinum-based chemotherapy and at least one other prior line of treatment. In essence, Keytruda was approved as third line treatment for this patient population. Lung cancer occurs when cells on the lung become abnormal and grow out of control. For SCLC it typically occurs for those who are smokers. It is estimated that SCLC accounts for between 10% to 15% of all lung cancer cases.
Marketing approval happened earlier than expected thanks to accelerated approval. The reason for achieving accelerated approval was because of the objective response rate (ORR) and duration of response (DOR) that were observed in studies. A couple of studies known as KEYNOTE-158 and KEYNOTE-028 used Keytruda as a monotherapy to treat these patients with SCLC. These patients had been able to show impressive responses and duration of response. Especially, since some patients had taken at least 2 or 3 prior lines of therapy.
