Keytruda Wins FDA Approval for Squamous NSCLC with Chemotherapy


This approval marks the first anti-PD-1 regimen for the first-line treatment of squamous non-small cell lung cancer regardless of tumor expression status.

Officials with the FDA have approved pembrolizumab (Keytruda, Merck) in combination with chemotherapy for the first-line treatment of metastatic squamous non-small cell lung cancer (NSCLC), according to a press release.

The expanded indication marks the first time an anti-PD-1 regimen has been approved in the first-line setting as both combination and monotherapy for squamous NSCLC, regardless of tumor PD-L1 expression status.

Pembrolizumab was previously granted approval in August for the first-line treatment of patients with metastatic non-squamous NSCLC, with no EGFR or ALK genomic tumor aberrations.

The latest approval is based on the phase 3 KEYNOTE-407 trial, which showed a significant improvement in overall survival in patients with metastatic squamous NSCLC, regardless of tumor PD-L1 expression status, and no prior systemic treatment for metastatic disease.

For the trial, 1 group of patients received pembrolizumab 200 mg plus carboplatin every 3 weeks for 4 cycles, plus paclitaxel every 3 weeks for 4 cycles or nab-paclitaxel on days 1, 8, and 15 of every 3-week cycle for 4 cycles, followed by pembrolizumab 200 mg every 3 weeks. The other group received a placebo and carboplatin every 3 weeks for 4 cycles, plus paclitaxel every 3 weeks for 4 cycles or nab-paclitaxel on days 1, 8, and 15 of every 3-week cycle for 4 cycles, followed by placebo every 3 weeks.

Overall, treatment with pembrolizumab and chemotherapy reduced the risk of death by 36% compared with chemotherapy alone (HR=0.64 [95% CI, 0.49, 0.85]; p=0.0017), according to the data. There was also a statistically significant improvement in progression-free survival and objective response rate.

“Today’s approval expands our current lung cancer indications to include combination treatment in patients with squamous cell carcinoma, a type of lung cancer that is particularly difficult to treat,” Dr Roger M. Perlmutter, president of Merck Research Laboratories, said in a statement. “Approval by the FDA has the potential to mean that Keytruda can be used to improve survival for more patients with this debilitating disease.”

According to Merck, the safety of pembrolizumab plus chemotherapy was evaluated in 101 patients at the first interim analysis of the trial. The treatment was discontinued for adverse reactions in 15% of patients. The most common adverse reactions reported in the trial were fatigue/asthenia, nausea, constipation, diarrhea, decreased appetite, rash, vomiting, cough, dyspnea, pyrexia, alopecia, and peripheral neuropathy.

Merck noted that immune-mediated adverse reactions can occur with pembrolizumab, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, severe skin reactions, solid organ transplant rejection, and complications of allogenic hematopoietic stem cell transplantation.


FDA Approves Merck’s Keytruda (pembrolizumab) in Combination with Carboplatin and Either Paclitaxel or Nab-Paclitaxel for the First-Line Treatment of Patients with Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC) [news release]. Merck’s website. Accessed October 31, 2018.

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