On June 12, China's National Medical Products Administration (NMPA) announced on its official website that Biotech Pharma's nivolumab has received approval for a new indication: combination therapy with gemcitabine for locally advanced or metastatic pancreatic cancer patients with wild-type K-Ras. Nivolumab was first launched in China in 2008 and became the country's first humanized monoclonal antibody approved specifically for pancreatic cancer treatment.

Nimotuzumab Ushers in a New Era of Pancreatic Cancer Treatment

Nimotuzumab's approval for pancreatic cancer was primarily based on the NOTABLE study, which was led by Professor Qin Shukai and Professor Li Jin. The study involved collaboration among 25 major research centers across China and culminated in a research paper selected for an oral presentation at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting—also earning recognition as one of the "Best of ASCO" and receiving an LBA (Lauded Best Abstract) designation.

The NOTABLE study is a prospective, randomized, double-blind, multicenter, registration-based Phase III clinical trial. In the experimental arm, patients received nimotuzumab in combination with gemcitabine: nimotuzumab was administered at 400 mg once weekly until disease progression or intolerability, while gemcitabine was given at 1,000 mg/m² on Days 1, 8, and 15, repeated every 4 weeks per treatment cycle—until disease progression or treatment intolerance occurred. The control group received placebo plus gemcitabine.

The study showed that the median overall survival was significantly prolonged in the nimotuzumab plus gemcitabine group, with 10.9 months versus 8.5 months in the control group (P = 0.024). Additionally, the 1-year survival rate improved by 63% in the nimotuzumab-plus-gemcitabine arm, reaching 43.6% compared to 26.8% in the control group (p = 0.024). The median progression-free survival (mPFS) was also markedly extended in the nimotuzumab-plus-gemcitabine group, with mPFS of 4.2 months versus 3.6 months in the control group (P = 0.013).

In terms of safety, the incidence of adverse events in the nimotuzumab plus gemcitabine group was similar to that in the control group.

CSCO Pancreatic Cancer Guidelines recommend Nivolumab as a Level 1 recommendation.

  Based on the promising data from the NOTABLE study, the CSCO Guidelines for the Diagnosis and Treatment of Pancreatic Cancer (2022 Edition) recommend Grade 1 the combination of nivolumab and gemcitabine as a first-line treatment option for K-Ras wild-type pancreatic cancer.