On September 16, 2021 Coherus BioSciences, Inc. ("Coherus", Nasdaq: CHRS) and Shanghai Junshi Biosciences Co., Ltd. ("Junshi Biosciences", HKEX: 1877; SSE: 688180) reported positive interim results from the pivotal study "JUPITER-06" (NCT03829969), a randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating toripalimab in combination with chemotherapy as a first-line therapy for patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC) (Press release, Coherus Biosciences, SEP 16, 2021, View Source [SID1234587814]). The study met the co-primary endpoints with statistically significant and clinically meaningful improvements in progression free survival (PFS) and overall survival (OS) for patients treated with the toripalimab and chemotherapy combination compared to chemotherapy alone.

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The results will be summarized by Dr. Feng Wang, Professor at Sun Yat-sen University Cancer Center (SYUCC), Guangzhou, in a mini-oral session during the ESMO (Free ESMO Whitepaper) Congress 2021 on Friday, September 17, 2021 at 12:05 pm Eastern Time. The abstract (#1373MO) is now available on the ESMO (Free ESMO Whitepaper) website.

"The findings of this interim analysis provide strong evidence that the addition of toripalimab to chemotherapy as a first-line treatment for advanced or metastatic ESCC patients has superior PFS and OS than chemotherapy alone," said Dr. Wang. "We look forward to updated analyses of overall survival of the JUPITER-06 study in the future and believe that these results will build a strong argument to support the use of toripalimab in combination with chemotherapy as a new standard first-line treatment in patients with advanced or metastatic ESCC."

"A strong and consistent efficacy and safety profile is emerging for toripalimab across multiple tumor types as data read out from pivotal clinical trials in melanoma, nasopharyngeal carcinoma, urothelial cancer, lung cancer and now also esophageal squamous cell carcinoma," said Dr. Patricia Keegan, Chief Medical Officer of Junshi Biosciences. "We believe toripalimab could be a potential new treatment choice where patients truly need better options. We will collaborate with Coherus to advance a BLA supplement for ESCC to make toripalimab available as quickly as possible for these patients in the U.S."

"With JUPITER-06, toripalimab has once again exhibited compelling efficacy in a first-line setting," said Denny Lanfear, CEO of Coherus. "The significant PFS and similarly robust overall survival data demonstrate that toripalimab in combination with chemotherapy could provide significant clinical benefits to patients with advanced or metastatic esophageal squamous cell carcinoma. We plan to work closely with our partner, Junshi Biosciences, to pursue a BLA supplement for this new indication expeditiously."

About JUPITER-06
A total of 514 treatment-naive advanced or metastatic patients were randomized (1:1) to receive toripalimab or placebo in combination with paclitaxel plus cisplatin chemotherapy followed by toripalimab or placebo maintenance. The primary endpoints were PFS as assessed by a blinded independent central review (BICR) and overall survival (OS).

At a prespecified interim analysis on March 22, 2021, with median follow-up of 7.4 and 7.3 months in the two arms, there was a significant improvement in OS for the toripalimab-chemotherapy arm compared to the placebo-chemotherapy arm (HR=0.58 [95% CI: 0.43-0.78], P=0.00037) with median OS of 17.0 vs. 11.0 months;

One-year OS rates were 66.0% vs.43.7% for the toripalimab-chemotherapy arm compared to the placebo-chemotherapy arm, respectively;

A significant improvement in PFS assessed by BICR was also detected for the toripalimab-chemotherapy arm compared to the placebo-chemotherapy arm (HR=0.58 [95% CI: 0.46-0.74], P<0.00001);

The OS and PFS benefits were observed across key subgroups, including all PD-L1 expression subgroups;

The incidence of Grade ≥3 adverse events (AEs) (73.2% vs 70.0%) and fatal AEs (8.2% vs 8.2%) were similar between the two arms. No new safety signals were observed.
Junshi Biosciences and Coherus are planning in 2022 to submit a biologics license application supplement to the United States Food and Drug Adminstration for toripalimab for first-line treatment, in combination with platinum-based chemotherapy, of advanced or metastatic ESCC. In China, the supplemental New Drug Application of this indication has been accepted by the National Medical Products Administration (NMPA) in July, 2021.

About Toripalimab
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 China and the United States. Ongoing or completed pivotal clinical trials are evaluating the efficacy and safety of toripalimab for a broad range of tumor types including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney and skin.

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 from 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, 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 designation for toripalimab in combination with chemotherapy for the 1st line treatment of recurrent or metastatic NPC and also for toripalimab monotherapy in second or third line 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 designations 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.