Toripalimab plus gemcitabine and cisplatin demonstrated a statistically significant and clinically meaningful improvement in overall survival compared with chemotherapy alone as frontline therapy in patients with recurrent or metastatic nasopharyngeal carcinoma.
Toripalimab plus gemcitabine and cisplatin demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) compared with chemotherapy alone as frontline therapy in patients with recurrent or metastatic nasopharyngeal carcinoma (NPC), according to final analysis from the phase 3 JUPITER-02 trial (NCT03581786).1
Data from the study will be submitted for presentation at an upcoming medical meeting.
“These mature overall survival data continue to demonstrate the benefit of toripalimab in the treatment of NPC patients, further building upon the data published in Nature Medicine and presented at the 2021 plenary session at the ASCO Annual Meeting, and clearly show that toripalimab has the potential to become the new standard-of-care for NPC patients, once approved,” Rosh Dias, MD, chief medical officer of Coherus, said in a press release. He added that there is currently no FDA-approved therapy for this aggressive head and neck tumor. “We look forward to sharing these data with the oncology community at an upcoming medical meeting.”
Previously, the FDA accepted for review a biologics license application (BLA) for toripalimab in combination with gemcitabine and cisplatin for the first-line treatment of patients with recurrent or metastatic NPC and as monotherapy for the second-line or later treatment of patients with recurrent or metastatic NPC following platinum-based chemotherapy.2
Thereafter, the company received a complete response letter to their BLA for toripalimab requesting a quality process change.3 In July 2022, the FDA accepted a revised BLA based on findings from the phase 2 POLARIS-02 trial (NCT02915432) and the phase 3 JUPITER-02 trial (NCT03581786).4
In phase 2 results, toripalimab induced an objective response rate of 20.5% (95% CI, 15.0%-27.0%) per independent review committee (IRC) assessment in pretreated patients with recurrent or metastatic NPC (n = 190).5
In the phase 3 data, the addition of toripalimab to gemcitabine and cisplatin resulted in a median progression-free survival (PFS) of 11.7 months (95% CI, 11.0–not evaluable) per blinded IRC assessment and by RECIST v1.1 criteria vs 8.0 months (95% CI, 7.0-9.5) with chemotherapy alone (stratified HR, 0.52; 95% CI, 0.36-0.74; P = .0003). The median OS had not been reached in either arm according to a data presentation made during the 2021 ASCO Annual Meeting (stratified HR, 0.603; 95% CI, 0.364-0.997; P = .0462).6
As of December 2022, the FDA had yet to send an action letter regarding the BLA for toripalimab in combination with chemotherapy.7 The BLA for toripalimab remains under review, and discussions are ongoing between the FDA and companies about pre-approval inspection plans.
“With the ongoing accumulation of data from the JUPITER-02 trial, we are thrilled to observe toripalimab gain more ground for becoming the preferred treatment for advanced NPC,” said Patricia Keegan, MD, chief medical officer of Junshi/TopAlliance Biosciences. “Compared to chemotherapy alone, a combination containing the immune checkpoint inhibitor, toripalimab, clearly has the potential to bring unprecedented changes to the extension of life in patients with NPC. We are looking forward to bringing this promising therapy to patients around the world.”