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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
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
“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
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.
“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
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 2021observation. 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.
Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 is thought to recharge the immune system’s ability to attack and kill tumor cells. More than thirty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally, including in
About Junshi Biosciences
Coherus is a commercial stage biopharmaceutical company with the mission to increase access to cost-effective medicines that can have a major impact on patients’ lives and to deliver significant savings to the health care system. Coherus’ strategy is to build a leading immuno-oncology franchise funded with cash generated by its commercial biosimilar business. For additional information, please visit www.coherus.com.
Coherus markets UDENYCA® (pegfilgrastim-cbqv) in
UDENYCA® is a trademark of
Avastin® and Lucentis® are registered trademarks of
Humira® is a registered trademark of AbbVie Inc.
Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Coherus’ ability to generate cash flow from its UDENYCA® business; Coherus’ and Junshi Biosciences’ ability to co-develop toripalimab, and Coherus’ ability to commercialize toripalimab, or any other drug candidates developed as part of its collaboration with Junshi Biosciences in the licensed territory; any market size expectation for checkpoint inhibitor therapeutic agents in
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
Coherus Contact Information:
+1 (650) 395-0152
+1 (949) 903-4750
Junshi Biosciences Contact Information
+ 86 021-2250 0300
+ 1 646-389-6658
+ 86 021-6105 8800
Source: Coherus BioSciences, Inc.