Positive Interim Results of CHOICE-01 Study Evaluating Coherus' and Junshi Biosciences? Toripalimab for First Line Treatment of Non-Small Cell Lung Cancer Presented at World Conference on Lun
REDWOOD CITY, Calif. and SHANGHAI, China , Sept. 13, 2021 (GLOBE NEWSWIRE) -- Coherus Biosciences, Inc. (Nasdaq: CHRS) and Shanghai Junshi Biosciences Co., Ltd. (?Junshi Biosciences?, HKEX: 1877; SSE: 688180) announced the presentation today of positive interim results from the pivotal study ?CHOICE-01? (NCT03856411), a randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating toripalimab plus chemotherapy as first-line treatment of advanced squamous or non-squamous non-small cell lung cancer (NSCLC) without driver mutations. The interim analysis met the primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression free survival (PFS) per RECIST v1.1 compared to chemotherapy alone.
The interim results were summarized?on September 13?in a presentation by Professor?Jie Wang, MD, PhD,?National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital,?Chinese Academy of Medical Sciences & Peking Union Medical College, during the Mini Oral Session at the 2021?World Conference on Lung Cancer?(WCLC) hosted by the?International Association for the Study of Lung Cancer?(IASLC). The?abstract?detailing the interim results was first made available on the WCLC website on August 18. ?The addition of toripalimab to standard 1st-line chemotherapy in patients with advanced non-small cell lung cancer showed superior progression free survival, overall response rate and duration of response over chemotherapy alone, with a safety profile consistent with the PD-1 inhibitor class of drugs,? said Dr. Wang. ?Overall survival data are still maturing, with a notable emerging trend favoring the toripalimab-chemotherapy combination. We look forward to additional data from this study and believe CHOICE-01 results will provide strong evidence to support the use of toripalimab with chemotherapy as a 1st-line therapeutic option for NSCLC.? A final analysis of progression free survival and an additional interim overall survival analysis are expected later this year. Junshi Biosciences and Coherus plan to meet with the?United States Food and Drug Administration?to discuss a potential submission to the pending biologics license application of an efficacy supplement for toripalimab for the first line treatment, in combination with platinum-based chemotherapy, of advanced, unresectable NSCLC without driver mutations. ?CHOICE-01 is the first of four pivotal clinical trials evaluating toripalimab for the treatment of lung cancer to have clinical data presented, and its positive results are a promising start for toripalimab in lung cancer. Lung cancer is the most common form of cancer worldwide and the leading cause of death due to cancer, so there is a clear need to develop complementary approaches to standard chemotherapy to improve patient outcomes, maintain quality of life, and seek to improve survival for patients diagnosed with this deadly disease. We will work closely with Coherus and the regulatory authorities to bring this new therapy to patients in the United States,? said Dr. Patricia Keegan, Chief Medical Officer of Junshi Biosciences. ?The CHOICE-01 interim data presented at WCLC are encouraging early evidence for toripalimab?s clinical benefit in the first-line setting in non-small cell lung cancer,? said Denny Lanfear, CEO of Coherus. ?We eagerly anticipate additional results from this study and the potential to advance toripalimab toward registration for this indication in the United States.? Toripalimab Phase 3 clinical trials in lung cancer Junshi Biosciences and Coherus are currently evaluating toripalimab in four pivotal Phase 3 clinical trials in lung cancer.- CHOICE-01, with 465 patients enrolled, is comparing toripalimab in combination with chemotherapy to chemotherapy alone as first-line treatment of advanced NSCLC. The study met the primary endpoint of progression free survival (PFS) at the interim analysis (data cut-off date: November 17, 2020). Patients receiving the placebo-chemotherapy combination were allowed to actively cross over to toripalimab treatment at the time of disease progression. Overall survival (OS) data are still maturing and exhibiting a trend favoring the toripalimab-chemotherapy arm as of a March 2021 observation. Final PFS and additional interim OS analyses are expected later in 2021.
- Toripalimab is also being evaluated in combination with standard platinum-based chemotherapy in patients with NSCLC harboring EGFR mutations whose tumors are no longer responding to EGFR TKI therapy. Enrollment of 350 subjects in this Phase 3 study is on track to be completed by the end of 2021. The primary endpoint of the study is PFS. Initial results are expected in 2022.
- In the neoadjuvant setting, toripalimab is being evaluated in combination with chemotherapy in a Phase 3 study with 406 patients with NSCLC scheduled to undergo surgical resection of their lung cancer. Enrollment is on track to be completed by the end of 2021. The primary endpoints of the study are major pathological response and event free survival. Initial results are expected in 2022.
- Toripalimab is being evaluated in combination with standard chemotherapy in a Phase 3 study with 442 patients with extensive stage small cell lung cancer. Enrollment is complete. PFS and OS are the co-primary endpoints. Results are expected by the first half of 2022.