Dr. Ou on the FDA Approval of Pembrolizumab in SCLC

Sai-Hong I. Ou, MD, PhD
Published: Tuesday, Jun 18, 2019



Sai-Hong Ignatius Ou, MD, PhD, Health Science Associate Clinical Professor, University of California, Irvine, Chao Family Comprehensive Cancer Center, University of California Irvine Medical Center, Orange, California, discusses the FDA approval of pembrolizumab (Keytruda) in small cell lung cancer (SCLC).

On June 18, 2019, the FDA granted an accelerated approval to pembrolizumab monotherapy for patients with metastatic SCLC who have disease progression on or after platinum-based chemotherapy and ≥1 other prior line of therapy.

Pooled results from cohorts of the phase II KEYNOTE-158 and phase Ib KEYNOTE-028 trials served as the basis for the approval. Results indicated that the PD-1 inhibitor induced a 19% overall response rate (ORR; (95% CI, 11%-29%) in patients with SCLC who had disease progression on or after platinum-based chemotherapy and ≥1 other prior line of therapy. Nivolumab (Opdivo) is also indicated in this setting, says Ou. It is hard to know how pembrolizumab will be incorporated in the paradigm, pending the results of the KEYNOTE-604 trial which is examining the combination of pembrolizumab and chemotherapy in the frontline setting, he adds. 
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Sai-Hong Ignatius Ou, MD, PhD, Health Science Associate Clinical Professor, University of California, Irvine, Chao Family Comprehensive Cancer Center, University of California Irvine Medical Center, Orange, California, discusses the FDA approval of pembrolizumab (Keytruda) in small cell lung cancer (SCLC).

On June 18, 2019, the FDA granted an accelerated approval to pembrolizumab monotherapy for patients with metastatic SCLC who have disease progression on or after platinum-based chemotherapy and ≥1 other prior line of therapy.

Pooled results from cohorts of the phase II KEYNOTE-158 and phase Ib KEYNOTE-028 trials served as the basis for the approval. Results indicated that the PD-1 inhibitor induced a 19% overall response rate (ORR; (95% CI, 11%-29%) in patients with SCLC who had disease progression on or after platinum-based chemotherapy and ≥1 other prior line of therapy. Nivolumab (Opdivo) is also indicated in this setting, says Ou. It is hard to know how pembrolizumab will be incorporated in the paradigm, pending the results of the KEYNOTE-604 trial which is examining the combination of pembrolizumab and chemotherapy in the frontline setting, he adds. 



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