NEW YORK – Junshi Biosciences said on Monday that in light of new Phase III data it will discuss plans to file a supplemental new drug application with regulatory authorities for its PD-1 antibody toripalimab in advanced triple-negative breast cancer.
In the randomized Phase III TORCHLIGHT study, Junshi is evaluating the combination of toripalimab plus chemotherapy versus placebo and chemo in patients with recurrent or metastatic TNBC.
An independent data monitoring committee determined as part of a recent interim analysis that the toripalimab combination improved progression-free survival versus just chemo among patients whose cancers express PD-L1. Toripalimab also showed a trend toward improving overall survival outcomes among patients with PD-L1-positive tumors as well as in all comers.
According to Shanghai-based Junshi, TORCHLIGHT is the first Phase III registration-directed immunotherapy trial to achieve a positive outcome in advanced triple-negative breast cancer patients in China.
Toripalimab, which is known by the brand name Tuoyi in China, is approved for several indications in China including as treatment for certain non-small lung cancer patients without EGFR or ALK mutations in combination with chemo. The US Food and Drug Administration is currently reviewing an application for toripalimab in advanced nasopharyngeal cancer.
"We will work closely with regulatory authorities to ensure that relevant indications are approved as soon as possible," Jianjun Zou, president of global R&D at Junshi, said in a statement. "We hope that toripalimab will provide better treatment options for patients and address unmet medical needs."