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Coherus and Junshi Biosciences Announce PD-1 Inhibitor Toripalimab Granted Orphan Drug Designation for Small Cell Lung Cancer in the United States
REDWOOD CITY, Calif., and SHANGHAI, China, April 14, 2022 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (“Coherus”, Nasdaq: CHRS) and Shanghai Junshi
About this update from Coherus Oncology, Inc.
[{"type":"text","content":"REDWOOD CITY, Calif., and SHANGHAI, China, April 14, 2022 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (“Coherus”, Nasdaq: CHRS) and Shanghai Junshi Biosciences Co., Ltd. (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) announced today that the United States Food and Drug Administration (\"FDA\") has granted Orphan Drug Designation (“ODD”) for toripalimab, a PD-1 inhibitor, for the treatment of small cell lung cancer (“SCLC”). ODD is granted to drugs intended to treat rare diseases with a patient population less than 200,000 in the United States. The designation provides incentives to advance development and commercialization of drugs that have the potential to provide benefit to patients with rare diseases. SCLC is an aggressive tumor characterized by rapid disease progression, low expression of PD-L1 and low levels of tumor infiltrating immune cells, as well as a high degree of immunosuppression. Efficacy of cancer immunotherapy has been limited in SCLC. No PD-1 inhibitors are currently approved in the United States for SCLC. Prognosis for SCLC patients is poor, with five year survival rates of approximately 20% and less than 5% for patients with extensive stage SCLC. The JUPITER-08 study (NCT04012606) is an ongoing, randomized, double-blind, placebo-controlled, multi-center Phase 3 clinical trial evaluating PD-1 inhibitor toripalimab in combination with chemotherapy (cisplatin or carboplatin + etoposide) compared to placebo in combination with chemotherapy as the first-line treatment of extensive stage SCLC. Enrollment in this trial has been completed. The co-primary endpoints of the study are overall survival and progression free survival as assessed by the investigator. “Toripalimab in combination with chemotherapy has demonstrated robust antitumor immunity and survival benefit in multiple tumor types including in tumors with low PD-L1 expression. This differentiated clinical activity may result from toripalimab’s unique binding epitope and internalization properties,” said Dr. Theresa LaVallee, Chief Development Officer at Coherus. “SCLC patients have a particularly poor prognosis, and new and better treatment options are clearly needed for patients with this aggressive cancer. We are pleased to be working closely with our partner, Junshi Biosciences, to evaluate toripalimab in this underserved patient population and look ...