The European Commission has approved Keytruda (pembrolizumab) for previously untreated metastatic non-small cell lung cancer (NSCLC) patients who have high PD-L1 expression and no EGFR or ALK mutations. It can now be marketed in all 28 European Union member states, as well as in Iceland, Norway, and Lichtenstein.
“The approval of Keytruda as a first treatment instead of chemotherapy for patients who express high levels of PD-L1 has the potential to transform the way metastatic non-small cell lung cancer is treated,” Roy Baynes, MD, PhD, senior vice president, head of clinical development, and chief medical officer at Merck Research Laboratories, said in a news release. “We are committed to ensuring that patients in Europe – who are in need of new treatment options – are able to quickly gain access to Keytruda.”
Data from the Phase 3 KEYNOTE-024 trial (NCT02142738) — a randomized, open-label study assessing Keytruda’s safety and efficacy versus standard of care — helped the commission make its decision. The study enrolled 305 patients with high PD-L1 expression (50% or more tumor cells expressed the protein) and no EGFR or ALK mutations.
Participants were randomized to receive a 200 mg infusion of Keytruda on the first day of each 21-day cycle for up to 35 cycles, or one of the following chemotherapy regimens for four to six cycles: Alimta (pemetrexed) plus Paraplatin (carboplatin); Alimta plus cisplatin; Gemzar (gemcitabine) plus cisplain; Gemzar plus Paraplatin, or Taxol (Paclitaxel) plus Paraplatin.
The study’s primary focus was progression-free survival, and secondary endpoints were overall survival and objective response rate.
Results showed Keytruda reduced the risk of progression or death by 50% compared to chemotherapy, and patients receiving the medication had a median progression-free survival of 10.3 months, compared to six months in the control arm.
Six- and 12-month progression-free survival rates were 62% and 48%, respectively, in the Keytruda group, compared to 50% and 15% in the chemotherapy arm.
Eighty percent of those taking Keytruda were still alive six months after treatment, and 70% were at 12 months. For those receiving chemotherapy, the overall survival rates were 72% and 54%, respectively.
Objective response rate — the percentage of patients who achieved a partial or complete response — was also higher in the Keytruda group (45% versus 28% for chemotherapy patients). Six people achieved a complete response, compared to one on chemotherapy. (Complete response is the disappearance of all signs of cancer in response to treatment. This does not always mean the cancer has been cured.)
“The data demonstrate that Keytruda provided meaningful improvements in survival versus the current standard of care in patients whose tumors express high levels of PD-L1,” said Luis Paz-Ares, MD, chair of the medical oncology department at Hospital Universitario Doce de Octubre in Madrid. “These findings supporting the approval also provide further rationale for biomarker testing in order to identify those patients more likely to benefit the most from treatment with Keytruda.”
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