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Merck's Keytruda Gets Two Bladder Cancer Approvals From FDA

19 May 2017

Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

The FDA granted regular approval to pembrolizumab for patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following chemotherapy.

Keytruda is being evaluated in over 30 tumor types in more than 400 clinical trials, at least half of which combine the drug with other cancer treatments. Keytruda has been approved for initial treatment of a type of bladder cancer called locally advanced or metastatic urothelial carcinoma, if patients are ineligible for cisplatin-containing chemotherapy. The median OS was 8.0 months (95% CI, 5.0-12.3 months) with pembrolizumab versus 5.2 months (95% CI, 4.0-7.4 months) with chemotherapy.

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).

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In this trial, pembrolizumab was discontinued due to adverse reactions in 11% of patients. Grade 3/4 treatment-related AEs were experienced by 16% of patients, and included fatigue (4%), muscle spasms (2%), decreased appetite (1%), and diarrhea (1%).

Patients who received pembrolizumab had fewer toxicities than those treated with chemotherapy.

Pembrolizumab also is approved for treatment of unresectable or metastatic melanoma; first-line treatment of patients with metastatic non-small cell lung cancer whose tumors have high PD-L1 expression but do not have EGFR or ALK genomic tumor aberrations; patients with metastatic, PD-L1-expressing NSCLC that progressed on or after platinum-containing chemotherapy; and patients with recurrent or metastatic head and neck squamous cell carcinoma that progressed on or after platinum-containing chemotherapy. Patients with autoimmune disease or a medical condition that required immunosuppression were excluded from the trial. Patients were randomized to receive either 200 mg of pembrolizumab every 3 weeks or the investigator's choice of paclitaxel, docetaxel, or vinflunine every 3 weeks. There were no statistically significant difference in progression-free survival between the two arms.

Pembrolizumab demonstrated superior OS compared to chemotherapy. Shares of the company have declined 2.3% over the last three months, compared with a 0.6% rise in the S&P 500.

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Merck announced in October that the second-line bladder cancer study met its main goal and was stopped early. The median PFS was 2.1 months (95% CI, 2.0-2.2 months) with the immunotherapy versus 3.3 months (95% CI, 2.3-3.5 months) with chemotherapy (P =.42). There were 218 events (81%) observed in the pembrolizumab arm, compared with 219 events (81%) in the chemotherapy arm (HR, 0.98; 95% CI, 0.81-1.19; P = 0.833).

The median OS for patients receiving Keytruda was 10.3 months compared with 7.4 months for those who received a chemotherapy regimen. In the study, there were statistically significant improvements in overall survival (OS) and objective response rate (ORR) for patients in the Keytruda group vs. chemotherapy. The ORR was 21% for pembrolizumab and 11% for chemotherapy.

The median duration of response in the Keytruda arm was not reached with an estimated 68 percent of responders considered likely to maintain a response for at least 12 months. The median follow-up time for this trial was 9.0 months. The most common adverse reaction resulting in permanent discontinuation of pembrolizumab was pneumonitis (1.9%).

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Merck's Keytruda Gets Two Bladder Cancer Approvals From FDA