Updated: Novartis rejigs late-stage plans for Cosentyx, next-gen CAR-T, TIGIT antibody and more

2023-02-01

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Novartis has cleaned up its Phase III slate, shelving late-stage plans for programs across inflammatory diseases and cancer, the Swiss pharma giant disclosed in its quarterly update — while also putting a mid-stage Huntington’s drug to bed and switching things up for a key rare disease candidate. The biggest change came in the decision to abandon a Phase III trial for Cosentyx, Novartis’ blockbuster IL-17A antibody, in active peripheral spondyloarthritis. It didn’t end up recruiting any of the 324 patients planned before terminating the trial earlier this month due to a “strategic decision of senior management,” according to records on clinicaltrials.gov. Cosentyx is already approved for multiple diseases, including plaque psoriasis and active psoriatic arthritis, bringing in more than $1 billion in revenue in the fourth quarter of 2022 alone. A development strategy update is also cited as the reason why Novartis didn’t start a pivotal trial for its next-gen CD19 CAR-T in second-line diffuse large B-cell lymphoma as planned. Dubbed YTB323 or rapcabtagene autoleucel, the cell therapy hits the same target as Novartis’ approved Kymriah but is made using a simplified manufacturing process. The change-up pushes back the anticipated regulatory submission for YTB323 from 2025 to beyond 2026, according to an investor presentation, with high-risk large B-cell lymphoma being the new lead indication. In an early trial, a high dose of YTB323 registered a 73% complete response rate among 15 patients. While Novartis had planned to start a new Phase III study for ociperlimab , the TIGIT antibody it licensed from BeiGene, for solid tumors in late 2022, it didn’t end up doing so — although it didn’t specify a reason. Moving into Phase II, Novartis revealed it’s officially discontinued branaplam in Huntington’s disease, “based on an overall assessment of potential benefit-risk” from the Phase II VIBRANT-HD study. Back in August, Novartis suspended dosing in the VIBRANT-HD study, citing fears of neuronal damage, but said it would need time to determine next steps. On iptacopan, the factor B inhibitor also known as LNP023 that CEO Vas Narasimhan has spotlighted as a top program, Novartis said it is shuttering a Phase II program in membranous nephropathy, citing “uncompellingcompetitive profile.” Meanwhile, it also expects a few months delay for the submissions in C3 glomerulopathy and IgA nephropathy, but noted that Phase III readouts are still expected in 2023. The planned submission for atypical haemolytic uraemic syndrome, though, is being pushed out to beyond 2026 as the company revealed slower than anticipated trial recruitment. The company also noted that it is still looking to out-license icenticaftor, a potentiator for the cystic fibrosis transmembrane conductance regulator (CFTR) protein that it developed to treat chronic obstructive pulmonary disease, or COPD. As remarked last quarter, Phase IIb data indicated a dose response across multiple endpoints. Editor’s note: Story updated to note that Novartis also reported updates to the branaplam and iptacopan programs.

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