FDA News

FDA grants priority review to Keytruda as part of non-small cell lung cancer regimen

The FDA granted priority review to a supplemental biologics license application that seeks approval of pembrolizumab for use in combination with pemetrexed and platinum chemotherapy for the treatment of patients with newly diagnosed metastatic nonsquamous non-small cell lung cancer.

Pembrolizumab (Keytruda, Merck) is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2.

The FDA based the priority review designation on results from the phase 3 KEYNOTE-189 trial, which assessed pembrolizumab in combination with pemetrexed (Alimta, Eli Lilly) and chemotherapy — either carboplatin or cisplatin — as first-line therapy for patients with metastatic nonsquamous NSCLC who did not harbor EGFR or ALK alterations.

The analysis included 616 patients with previously untreated stage IV nonsquamous NSCLC.

Researchers randomly assigned 410 patients to pembrolizumab 200 mg, pemetrexed 500 mg/m2, and either carboplatin area under the curve 5 or cisplatin 75 mg/m2. The other 206 patients received placebo plus chemotherapy.

As HemOnc Today previously reported, results presented at this year’s American Association for Cancer Research Annual Meeting showed the addition of pembrolizumab to chemotherapy significantly improved PFS, OS and overall response rate among all patient groups regardless of PD-L1 expression.

A similar percentage of patients assigned pembrolizumab and placebo experienced grade 3 or higher adverse events (67.2% vs. 65.8%).

Most toxicities were expected, except for an elevated rate of acute kidney injury in the pembrolizumab group (overall incidence, 5.2% with pemetrexed vs. 0.5% with placebo; grade 3 to grade 5 incidence, 2% vs. 0%).

“Keytruda is the first immunotherapy to significantly extend survival of patients with nonsquamous non-small cell lung cancer in combination with chemotherapy as a first-line treatment, including [among] patients whose tumors are either PD-L1 negative or are untested,” Roger M. Perlmutter, president of Merck Research Laboratories, said in a company-issued press release. “With this supplemental biologics license application acceptance by the FDA, we are pleased that data from KEYNOTE-189 is now under review by regulatory authorities in the United States, Europe and Japan.”

The FDA set an action date of Sept. 23.

Pembrolizumab already is approved for several indications in the United States, including treatment of specific patients with NSCLC, melanoma, head and neck squamous cell carcinoma, classical Hodgkin lymphoma, urothelial carcinoma, gastric or gastroesophageal junction adenocarcinoma, and unresectable or metastatic microsatellite instability-high or mismatch repair-deficient cancers.

The FDA granted priority review to a supplemental biologics license application that seeks approval of pembrolizumab for use in combination with pemetrexed and platinum chemotherapy for the treatment of patients with newly diagnosed metastatic nonsquamous non-small cell lung cancer.

Pembrolizumab (Keytruda, Merck) is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2.

The FDA based the priority review designation on results from the phase 3 KEYNOTE-189 trial, which assessed pembrolizumab in combination with pemetrexed (Alimta, Eli Lilly) and chemotherapy — either carboplatin or cisplatin — as first-line therapy for patients with metastatic nonsquamous NSCLC who did not harbor EGFR or ALK alterations.

The analysis included 616 patients with previously untreated stage IV nonsquamous NSCLC.

Researchers randomly assigned 410 patients to pembrolizumab 200 mg, pemetrexed 500 mg/m2, and either carboplatin area under the curve 5 or cisplatin 75 mg/m2. The other 206 patients received placebo plus chemotherapy.

As HemOnc Today previously reported, results presented at this year’s American Association for Cancer Research Annual Meeting showed the addition of pembrolizumab to chemotherapy significantly improved PFS, OS and overall response rate among all patient groups regardless of PD-L1 expression.

A similar percentage of patients assigned pembrolizumab and placebo experienced grade 3 or higher adverse events (67.2% vs. 65.8%).

Most toxicities were expected, except for an elevated rate of acute kidney injury in the pembrolizumab group (overall incidence, 5.2% with pemetrexed vs. 0.5% with placebo; grade 3 to grade 5 incidence, 2% vs. 0%).

“Keytruda is the first immunotherapy to significantly extend survival of patients with nonsquamous non-small cell lung cancer in combination with chemotherapy as a first-line treatment, including [among] patients whose tumors are either PD-L1 negative or are untested,” Roger M. Perlmutter, president of Merck Research Laboratories, said in a company-issued press release. “With this supplemental biologics license application acceptance by the FDA, we are pleased that data from KEYNOTE-189 is now under review by regulatory authorities in the United States, Europe and Japan.”

The FDA set an action date of Sept. 23.

Pembrolizumab already is approved for several indications in the United States, including treatment of specific patients with NSCLC, melanoma, head and neck squamous cell carcinoma, classical Hodgkin lymphoma, urothelial carcinoma, gastric or gastroesophageal junction adenocarcinoma, and unresectable or metastatic microsatellite instability-high or mismatch repair-deficient cancers.

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