Merck & Co.'s Keytruda gains accelerated FDA approval for previously treated patients with metastatic SCLC

Merck & Co. announced Tuesday that the FDA granted accelerated approval to Keytruda (pembrolizumab) as monotherapy for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. The company noted that this is the first clearance of the anti-PD-1 therapy in SCLC.

Approval of Keytruda in this indication, which comes after the therapy was granted priority review in February, was supported by pooled data from certain cohorts of the KEYNOTE-158 and KEYNOTE-028 studies. Results unveiled earlier this year showed that Keytruda was associated with an overall response rate of 19.3% in 83 patients, including two complete responses and 14 partial responses, while the duration of response exceeded 18 months in 56% of the responders.  

The latest authorisation marks the third US clearance for Keytruda this month following approvals for the first-line treatment of patients with metastatic or unresectable, recurrent head and neck squamous cell carcinoma (HNSCC) whose tumours express PD-L1 and use in combination with platinum and 5-fluorouracil as a first-line treatment for patients with metastatic or unresectable HNSCC regardless of PD-L1 expression. The product generated $2.3 billion in sales in the first quarter, reflecting year-on-year growth of 55% (for additional analysis, read ViewPoints: Key takeaways from Merck & Co.'s Q1 earnings and investor call).

In March, the FDA approved Roche's Tecentriq (atezolizumab), in combination with chemotherapy, for the first-line treatment of adults with extensive-stage SCLC, making the PD-L1 inhibitor "the first cancer immunotherapy" authorised in this indication. The approval was based on results showing that patients given Tecentriq plus standard chemotherapy lived significantly longer compared with chemotherapy alone, at 12.3 months versus 10.3 months, respectively. For related analysis, see ViewPoints: A timely approval for Tecentriq in SCLC as Roche looks to lead from the front.

Meanwhile, Bristol-Myers Squibb's PD-1 inhibitor Opdivo (nivolumab) gained accelerated FDA approval last year for patients with metastatic SCLC, whose disease has progressed after platinum-based chemotherapy and at least one other line of therapy. The clearance was based on data showing that 12% of patients responded to treatment with Opdivo, regardless of PD-L1 expression, with a median duration of response of 17.9 months. However, Bristol-Myers Squibb later reported that Opdivo failed to significantly prolong overall survival versus current standard of care in patients with SCLC who relapsed following platinum-based chemotherapy.

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