Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has received a new indication approval from China’s National Medical Products Administration (NMPA) for its anti-PD-1 therapy, Loqtorzi (toripalimab). The drug is now approved for use in combination with axitinib to treat first-line moderate- to high-risk unresectable or metastatic renal cell carcinoma (RCC), marking a significant milestone as the first immunotherapy for kidney cancer in China.
The approval comes on the heels of positive results from the RENOTORCH study, a multi-center, randomized Phase III trial that enrolled 421 patients. The study compared the efficacy of toripalimab combined with axitinib or sunitinib at a 1:1 ratio, against sunitinib alone. The combination therapy significantly prolonged patient progression-free survival (PFS) to 18.0 months, compared to 9.8 months with sunitinib, reducing the risk of disease progression or death by 35%. The overall response rate (ORR) also saw a significant improvement, with 56.7% versus 30.8% for sunitinib, and a longer duration of response (DoR), with the median DoR not reached for the toripalimab regimen versus 16.7 months for sunitinib. There were clear signs of overall survival (OS) benefit, with the median OS not reached for the toripalimab regimen versus 26.8 months for sunitinib, equating to a 39% reduction in mortality risk. The therapy also demonstrated good safety and tolerability, with no new safety signals emerging.
This approval expands the utility of toripalimab, which was China’s first domestic PD-1 inhibitor approved as a second-line treatment for melanoma in December 2018. With this new indication, Junshi Biosciences continues to strengthen its position in the immuno-oncology space, offering innovative treatment options for patients in China and globally.- Flcube.com
