Tislelizumab: A Step Closer to Approval in the US After Another Phase III Victory!

BeiGene scored a major success on Thursday, with the announcement that its Phase III trial for tislelizumab had yielded positive results for patients with a type of gastric cancer. The study met its primary objective of improved overall survival in patients with advanced, inoperable or metastatic gastric or gastroesophageal junction adenocarcinoma, regardless of PD-L1 status. This marks yet another victory for the innovative biotech, which is revolutionizing the fight against cancer.

BeiGene is excited to share the new findings of its drug G/GEJ with regulatory authorities, in the hopes of adding it to the list of drugs approved in China for 10 indications. According to Chief Medical Officer Mark Lanasa, the company is eager to discuss the data and move forward with the approval process.

Novartis has been met with great success in its marketing of Kymriah, a revolutionary cell-based therapy, in Asia. However, in the U.S. and Europe, the company has yet to receive the same level of approval for the product. Despite that, Novartis is still determined to make Kymriah accessible to those who need it.

Novartis recently made waves in the medical world by purchasing the rights to co-develop and commercialize tislelizumab, a checkpoint inhibitor, from BeiGene. Last summer, the Biologics License Application (BLA) for tislelizumab to be used as a first-line treatment in combination with chemotherapy for certain types of esophageal cancer was unfortunately delayed indefinitely by the FDA.

However, the rights to develop and commercialize tislelizumab for multiple cancer indications in North America, Japan, the E.U., and six other European countries have been secured by Novartis, giving hope to patients and their families.

COVID-19 travel restrictions prevented the agency from inspecting the manufacturing facilities in China, leaving the review timeline uncertain.

The FDA is gearing up to perform manufacturing inspections this quarter, according to Lanasa of BioSpace. This is a major milestone for the agency, signaling their commitment to ensure the safety and quality of products entering the market.

Lanasa expressed optimism in the results of the inspection, noting that it could provide a crucial step forward in the FDA’s final decision on whether to approve the treatment for esophageal squamous cell carcinoma (ESCC) as a second-line option.

Dr. Michael F. Tetzlaff, the Chief Development Officer of BeiGene, expressed confidence that the company will overcome the recent regulatory hurdle and be able to submit their frontline study in ESCC and their new Phase III data in gastric cancer. He said, “Once we can get over this hurdle, which we are confident that we will, it will allow additional submissions to go forward.”

In a groundbreaking clinical trial, tislelizumab was pitted against a placebo-chemo combo as a first-line treatment in G/GEJ adenocarcinoma patients. The results showed that tislelizumab increased the median overall survival to 17.2 months, compared to 12.6 months in the chemo plus placebo group – a remarkable achievement with no new safety signals identified.

Novartis has recently made the decision to scrap its filing of tislelizumab for non-small cell lung cancer. According to CEO Vas Narasimhan, the FDA’s analysis of the data revealed that the studies weren’t up to standard for approval. In order to be approved, the studies must be “global in nature, have an appropriate amount of U.S. patients, and that the standard of care used reflects standard of care in the U.S.,” explained Narasimhan. Unfortunately, the data wasn’t able to meet these expectations, leading to the termination of the filing.

Novartis made a major move late last year when they announced they would be including gastric cancer in their pipeline for tislelizumab. This was backed up by the RATIONALE 305 study, a global multi regional study conducted in the United States and other areas, which aimed to assess the efficacy of the drug. This could be a major breakthrough in the treatment of gastric cancer, and could revolutionize the way it is treated in the future.

Tislelizumab is an increasingly popular cancer drug with an impressive list of potential applications. According to clinical trials listings, it is currently being tested for 234 different types of cancer and has 21 registration-enabling trials in the works. With such a comprehensive scope of potential applications, tislelizumab is quickly becoming the go-to drug for oncologists around the world.

Leave a Comment