FDA Approves Keytruda for Lung Cancer After Surgery

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This approval marks the fifth indication for Keytruda-based regimens in non-small cell lung cancer and the 34th indication in the United States.

The FDA has approved Merck’s Keytruda (pembrolizumab) to treat patients with non-small cell lung cancer (NSCLC) following surgery and chemotherapy. Lung cancer is the leading cause of cancer death worldwide. Non-small cell lung cancer is the most common type of lung cancer, accounting for about 81% of all cases. In the United States, the overall five-year survival rate for patients diagnosed with lung cancer is 25%, which is a 21% improvement over the last five years.

Roy S. Herbst, M.D., Ph.D.

Roy S. Herbst, M.D., Ph.D.

“While there have been many advances for patients with metastatic disease, surgery remains the typical treatment for people with stage IB, II and IIIA non-small cell lung cancer. Unfortunately, many of these patients who undergo surgery still see their disease return,” Roy S. Herbst, M.D., Ph.D., deputy director and chief of medical oncology, Yale Cancer Center and Smilow Cancer Hospital, said in a press release. “Today’s approval for Keytruda offers a new, important immunotherapy treatment option for stage IB, II, or IIIA patients with non-small cell lung cancer following surgery and adjuvant chemotherapy.”

With this approval, Keytruda is the only immunotherapy with an approved option for NSCLC regardless of PD-L1 expression in both the adjuvant and metastatic settings. In addition to this approval, Keytruda indicated

  • in combination with pemetrexed and platinum chemotherapy for the first-line treatment of patients with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations;
  • in combination with carboplatin and either paclitaxel or paclitaxel protein-bound for the first-line treatment of patients with metastatic squamous NSCLC;
  • as a single agent for the first-line treatment of patients with NSCLC expressing PD-L1, with no EGFR or ALK genomic tumor aberrations;
  • and as a single agent for the treatment of patients with metastatic NSCLC whose tumors express PD-L1, with disease progression on or after platinum-containing chemotherapy.

The newest approval is based data from the phase 3 KEYNOTE-091 trial, which enrolled 1,177 patients with completely resected stage IB or IIIA non-small cell lung cancer. The major efficacy outcome measure was disease-free survival (DFS). In patients who received adjuvant platinum-based chemotherapy following surgical resection, Keytruda reduced the risk of disease recurrence or death by 27% versus placebo regardless of PD-L1 expression. The median disease-free survival in patients was nearly five years (58.7 months) for the Keytruda arm versus nearly three years (34.9 months) for the placebo arm.

The adverse reactions were generally similar to those occurring in other patients with NSCLC receiving Keytruda, with the exception of hypothyroidism (22%), hyperthyroidism (11%), and pneumonitis (7%). Two fatal adverse reactions of myocarditis occurred.

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