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 Lung Cancer
September 13, 2021 at 20:35 PM EDT
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
In China, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI®). On December 17, 2018, toripalimab was granted a conditional approval by the National Medical Products Administration (NMPA) for the second-line treatment of unresectable or metastatic melanoma. In December 2020, toripalimab was successfully included in the updated National Reimbursement Drug List. In February 2021, the NMPA granted a conditional approval to toripalimab for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy. In April 2021, NMPA granted a conditional approval to toripalimab for the treatment of patients with locally advanced or metastatic urothelial carcinoma who failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. In addition, two supplemental NDAs for toripalimab in combination with chemotherapy for the first-line treatment of patients with advanced, recurrent or metastatic NPC or for the first-line treatment of patients with advanced, or metastatic esophageal squamous cell carcinoma were accepted by the NMPA for review in February and July 2021 respectively.
In the United States, the first toripalimab BLA has been submitted to the FDA for the treatment of recurrent or metastatic NPC. The FDA has granted Breakthrough Therapy designations for toripalimab in combination with chemotherapy for the 1st line treatment of recurrent or metastatic NPC and for toripalimab monotherapy in the 2nd line and subsequent treatment of recurrent or metastatic NPC. There are currently no PD-1 blocking antibodies approved for use in NPC in the United States. Additionally, FDA has granted Fast Track designation for toripalimab for the treatment of mucosal melanoma and orphan drug designation for NPC, mucosal melanoma and soft tissue sarcoma. Earlier in 2021 Coherus in-licensed rights to develop and commercialize toripalimab in the United States and Canada. Coherus and Junshi Biosciences plan to file additional toripalimab BLAs with the FDA over the next three years for multiple rare cancers and highly prevalent cancers.
About Junshi Biosciences
About Coherus BioSciences
Coherus markets UDENYCA® (pegfilgrastim-cbqv) in the United States and through 2023 expects to launch toripalimab, an anti-PD-1 antibody, as well as biosimilars of Lucentis®, Humira®, and Avastin®, if approved.
UDENYCA® is a trademark of Coherus BioSciences, Inc.
Avastin® and Lucentis® are registered trademarks of Genentech, Inc.
Humira® is a registered trademark of AbbVie Inc.
Such forward-looking statements involve substantial risks and uncertainties that could cause Coherus’ actual results, performance or achievements to differ significantly from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the risks and uncertainties inherent in the clinical drug development process; the risks and uncertainties of the regulatory approval process, including the timing of Coherus’ regulatory filings; the risk that Coherus is unable to complete commercial transactions and other matters that could affect the availability or commercial potential of Coherus’ drug candidates; and the risks and uncertainties of possible patent litigation. All forward-looking statements contained in this press release speak only as of the date on which they were made. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Coherus’ business in general, see Coherus’ Annual Report on Form 10-K for the year ended December 31, 2020, filed with the Securities and Exchange Commission on February 25, 2021,its Quarterly Report on Form 10-Q for the three and six months ended June 30, 2021, filed with the Securities and Exchange Commission on August 5, 2021 and its future periodic reports to be filed with the Securities and Exchange Commission. Results for the quarter ended June 30, 2021 are not necessarily indicative of our operating results for any future periods.
Coherus Contact Information:
Junshi Biosciences Contact Information