Coherus and Junshi Biosciences Announce Positive Interim Results of CHOICE-01, a Phase 3 Clinical Trial Evaluating Toripalimab in Combination with Chemotherapy as First-Line Treatment for Non
SHANGHAI, China?and?REDWOOD CITY, Calif.,?Aug. 18, 2021?(GLOBE NEWSWIRE) --?Shanghai Junshi Biosciences Co., Ltd.?(?Junshi Biosciences?, HKEX: 1877; SSE: 688180) and?Coherus BioSciences, Inc.?(?Coherus?, Nasdaq: CHRS), today announced 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). 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 results will be summarized?September 13?in an oral 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?is now available on the WCLC website.
?The CHOICE-01 study in patients with advanced non-small cell lung cancer has demonstrated the clinical benefit of toripalimab in yet another first-line setting, building on the evidence of efficacy in first-line studies in nasopharyngeal carcinoma and esophageal squamous cell carcinoma,? said Dr.?Patricia Keegan, Chief Medical Officer at Junshi Biosciences. ?With an excellent clinical profile being established across multiple tumor types, we expect to pursue registration for toripalimab for a broad array of indications in?China,?the United States?and other markets.?
?The CHOICE-01 efficacy and safety data are compelling and demonstrate the potential for toripalimab to deliver the significant benefits of the PD-1 class of checkpoint inhibitor drugs to patients with non-small cell lung cancer,? said?Ildiko Csiki, MD, PhD, Chair of the?Coherus Scientific Advisory Board and Chief Commercial Research?and Development Officer at City of Hope, a comprehensive cancer center. ?As data accumulate in the pivotal studies in the broad clinical development program, toripalimab is showing itself to be an excellent checkpoint inhibitor. We eagerly anticipate results from additional Phase 3 studies in esophageal, lung, liver, breast, kidney, bladder, stomach, and skin cancers.?
About CHOICE-01
A total of 465 treatment-naive advanced NSCLC patients (220 squamous and 245 non-squamous) were randomized (2:1): 309 to the toripalimab plus chemotherapy arm and 156 to the placebo plus chemotherapy arm. The primary endpoint of PFS was assessed by the investigator. Secondary endpoints included PFS assessed by a blinded independent review committee (BIRC), overall survival (OS), objective response rate (ORR) and duration of response (DoR). Crossover to toripalimab was allowed for patients from the placebo plus chemotherapy arm upon disease progression.
- As of?November 17, 2020?(the data cut-off date of the interim analysis), 218 PFS events were observed, with a median follow-up of 7.1 and 7.0 months in the toripalimab arm and the placebo arm, respectively.
- At the interim analysis, a significant improvement in PFS was detected for toripalimab over placebo [hazard ratio (HR)=0.58,95% confidence interval (CI): 0.44-0.77, P=0.0001] with median PFS of 8.3 vs. 5.6 months. The 1-year PFS rates for toripalimab and placebo arms were 32.6% and 13.1%, respectively.
- This improvement in PFS was observed in both squamous [HR = 0.55 (95% CI: 0.38-0.83)] and non-squamous [HR=0.59 (95% CI: 0.40-0.87)] NSCLC and regardless of PD-L1 expression.
- PFS assessed by BIRC showed similar results as PFS assessed by the investigator.
- Toripalimab in combination with chemotherapy, as compared with chemotherapy alone, resulted in better ORR (squamous NSCLC: 68.7% vs. 58.9%; non-squamous NSCLC: 58.6% versus 26.5%) and median DoR (squamous NSCLC: 6.9 months?vs. 4.2 months; non-squamous NSCLC: 8.6 months vs. 5.1 months).
- Patients in the placebo plus chemotherapy arm were actively crossed over to toripalimab treatment at the time of disease progression.
- Overall survival data were not yet mature as of?March 7, 2021. There was a trend favoring the toripalimab arm [median OS of 21.0 vs. 16.0 months, HR = 0.81 (95% CI: 0.57-1.17)].
- The addition of toripalimab to standard first-line chemotherapy in patients with advanced NSCLC showed a manageable safety profile with no new safety signal observed. The incidence of Grade =3 adverse events (AEs) was 76.3% in the toripalimab arm?vs. 80.1% in the control arm. AEs leading to discontinuation of toripalimab or placebo were 12.3% vs. 1.9%, respectively.