MRK - Oncotelic gets FDA nod for mid-stage trial design for lead asset and Keytruda combo

Clinical-stage biotech Oncotelic Therapeutics (OTCQB:OTLC) announced on Wednesday that the Food and Drug Administration (FDA) cleared the Phase 2 trial protocol for the company’s lead candidate OT-101 in combination with Merck’s (MRK) Keytruda in mesothelioma. The company plans to start the investigator-initiated study involving patients with metastatic plural mesothelioma (MPM) in collaboration with Merck (MRK) which supplies the Keytruda (pembrolizumab) for the trial. The open label, non-randomized trial is expected to enroll up to 63 patients in the U.S. across several clinical sites. Its main goal will be to assess if the therapeutic combination can improve tumor response in MPM patients who fail to mount or maintain a response to anti-PD-1/PD-L1-based treatment regimens. The announcement of the Phase 2 mesothelioma study for the lead candidate comes days after Oncotelic (OTCQB:OTLC) appointed its new medical chief Fatih Uckun.

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Oncotelic gets FDA nod for mid-stage trial design for lead asset and Keytruda combo