Novartis sheds several US PD-1 filing plans and another anti-CD40 drug indication – Endpoints News

Novartis sheds several US PD-1 filing plans and another anti-CD40 drug indication – Endpoints News

Buried in Novartis’ third quarter report were a few key indication drops.

First, Novartis no longer plans to submit tislelizumab for FDA approval in first-line nasopharyngeal cancer or first-line non-small cell lung cancer alongside chemotherapy – marking two more US regulatory setbacks for the PD-1 checkpoint inhibitor that Novartis gave BeiGene for 650 million dollars for rights to the USA and ex-China.

Previously, Novartis guided that it would submit tislelizumab in nasopharyngeal cancer in the second half of the year. In an emailed statement, Novartis said:

Novartis has decided not to proceed with the application in the US for tislelizumab as monotherapy in recurrent or metastatic nasopharyngeal cancer (NPC) based on regulatory feedback. We remain confident in tislelizumab and look forward to bringing it to market and will prioritize other indications for submission in the US, while expanding our development program to further investigate the potential of new, synergistic combinations.

In July, the FDA delayed its decision on the drug indefinitely in esophageal cancer. According to Novartis and BeiGene at the time, the FDA delay in esophageal cancer came as the regulatory agency “was unable to conduct necessary inspections in China due to COVID-19-related travel restrictions.” A few weeks later, CEO Vas Narasimhan revealed in the pharma’s Q2 call that Novartis and BeiGene no longer planned to submit tislelizumab for approval in the US as a second- or third-line monotherapy for non-small cell lung cancer.

In April, the duo announced that European authorities are evaluating their drug in both esophageal and non-small cell lung cancer.

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Had tislelizumab been approved in the US, it would have become the first checkpoint inhibitor developed in China to enter the US market. As more checkpoint inhibitors are developed, new entries from China hoped to compete on price — a tactic that Eli Lilly and its partner Innovent described, although they were later shot down by the FDA for submitting clinical trial data only from China.

While tislelizumab is approved for a number of cancers in China, it remains unclear what lies ahead for the drug in the United States.

In addition, Novartis is dropping the indication for liver transplantation from its iscalimab program. According to the Q3 report, the anti-CD40 drug, which is intended to prevent liver organ rejection, showed a “less favorable benefit/risk profile compared to tacrolimus” in a phase II study. In an emailed statement, Novartis noted that it stopped the trial after seeing results from an interim analysis conducted when 80% of patients reached six months on treatment or discontinued before six months. The trial enrolled 132 people, according to

Novartis had hoped that the antibody would become the new standard of care in transplants. By late 2020, Narasimhan had highlighted the drug as a promising program in the middle. But last September, Novartis ended its kidney transplant program after it was less effective than the standard of care.

Novartis is still testing the drug in Sjögren’s syndrome, hidradenitis suppurativa (aka acne inversa), lupus and type 1 diabetes.

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