Pembrolizumab Granted Approval for Advanced or Metastatic Urothelial Carcinoma
Pembrolizumab Granted Approval for Advanced or Metastatic Urothelial Carcinoma
Results will be presented at ASCO in Chicago next month
19 May, 2017, 06:43
In addition to Tecentriq's approval for bladder cancer patients whose disease has stopped responding to chemotherapy, the FDA last month approved the Roche drug as an initial treatment for people with a specific type of advanced bladder cancer and in people whose bladder cancer progressed despite at least one prior platinum-containing chemotherapy.
Merck said data from an open-label Phase 3 trial of 542 advanced bladder cancer patients showed median survival of 10.3 months for Keytruda patients and 7.4 months for patients given second-line chemotherapy. The accelerated approval was based on data from the single-arm, open-label KEYNOTE-052 trial in 370 patients who received 200 mg of pembrolizumab every 3 weeks.
Patients in that trial received 200 mg pembrolizumab every 3 weeks (n = 270) or investigator's choice of a chemotherapy regimen - which included paclitaxel, docetaxel or vinflunine - every 3 weeks (n = 272).
The median OS was 10.3 months vs. 7.4 months for the Keytruda and chemotherapy arms, respectively (hazard ratio [HR] 0.73, 95% CI: 0.59, 0.91; P=0.004).
At a median follow-up of 7.8 months, the ORR was 28.6% (95% CI, 24-34) and the median response duration was not reached (range 1.4+ to 17.8+ months).
Pivotal trial results for Merck & Co Inc's immunotherapy drug Keytruda show that it lengthened survival by three months, or almost 40 percent, for patients with advanced bladder cancer who had stopped responding to chemotherapy. No significant difference in progression-free survival between the 2 arms was observed.
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According to the FDA, "an additional trial is required to confirm clinical benefit of pembrolizumab for the first-line indication".
Treatment-related AEs occurring in 10 percent or more of participants were generally lower with Keytruda as opposed to chemotherapy, respectively, including for fatigue (13.9 percent vs 27.8 percent), nausea (10.9 percent vs 24.3 percent), diarrhea (9.0 percent vs 12.9 percent), asthenia (5.6 percent vs 14.1 percent), and anemia (3.4 percent vs 24.7 percent with chemotherapy). Immune-related AEs that were higher with Keytruda compared with chemotherapy, respectively, included thyroid abnormalities (9.4 percent vs 1.6 percent), pneumonitis (4.1 percent vs 0.4 percent) and colitis (2.3 percent vs 0.4 percent).
Fifteen patients in the pembrolizumab arm and 28 patients in the chemotherapy group discontinued treatment due to a treatment-related AE.
The median age for the first 100 patients was 75 years (range, 44-94), and 87 percent had visceral metastases at baseline. The CR rate was 7% and the partial response rate was 22%. In either of the 2 trials, the most common adverse events (AEs) reported in at least 205 patients treated with pembrolizumab was fatigue, musculoskeletal pain, pruritus, decreased appetite, nausea, diarrhea, constipation, and rash.
The accelerated approval for frontline Keytruda in urothelial carcinoma is contingent on the results of a confirmatory trial. Keytruda is already approved for treating melanoma, lung cancer, head and neck cancer, and Hodgkin lymphoma.
Balar A, Bellmunt J, O'Donnell PH, et al. Presented at: 2016 ESMO Congress; October 7-11, 2016; Copenhagen, Denmark.
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