nivolumab biosimilar / NeuClone, Serum Institute of India - LARVOL DELTA

Final results: Dose escalation study of a personalized peptide-based neoantigen vaccine in patients with metastatic melanoma. (ASCO 2023) - P1/2 | "Here, we report on a first-in-human clinical trial evaluating a personalized neoantigen vaccine (EVX-01) in patients with metastatic melanoma...All patients received monotherapy with pembrolizumab (11) or nivolumab (1) during the vaccine manufacturing period... aPD-1 treatment combined with a peptide-based personalized neo-antigen-based vaccine was shown to be feasible and safe with promising signs of efficacy, warranting further study. Further, the neo-antigen selection method appeared crucial for designing an efficacious vaccine. Clinical trial information: NCT03715985."

Clinical • Metastases • Tumor-specific neoantigens • Fatigue • Melanoma • Oncology • Solid Tumor • CD4

"🥁Thrilled to announce that our paper is out @NatureMedicine! We looked at the impact of nivolumab/ipilimumab +/- #CBM588 a bifidogenic live bacterial product, on gut #Microbiome, serum cytokines & clinical outcomes in #mRCC 🙏🙏@montypal @LuisMezaco @PauloBergerot et al. 1/n🧵" (@NazliDizman)

Clinical • Clinical data • Renal Cell Carcinoma

FDA Takes a Stand on Accelerated Immunotherapy Approvals Without Confirmatory Benefit (Targeted Oncology) - "The study really did confirm the activity of pembrolizumab. We saw a response rate of 18%, which was very durable,' said lead author Richard S. Finn, MD, on the results of the KEYNOTE-240 trial in an interview with Targeted Therapies in Oncology. 'This study clearly showed that pembrolizumab helps a subset of patients and is well tolerated, confirming the safety data. The ‘near miss,’ so to speak, statistically suggests that had the study been designed differently from a statistical standpoint, either [if it had been] larger or not included as many interim analyses or coprimary end points, that very likely we could have hit that statistical end point'....'I think the accelerated approval pathway is important, I think we need to maintain it. Personally, I believe that maintaining access to treatment options for patients is important....In that, if you rescind a first-line label, then you’re essentially requiring all patients to have to go through..."

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