Register Now: From Clinical to Commercial: Accelerating ADC Late-Stage Development with Technology Innovation and Integrated Platform
News|Podcasts|April 20, 2026

The BioPharm Brief: Oncology Innovations Continue with Durable Survival, In Vivo CAR-T, and Combination Therapies

Long-term survival data, scalable cell engineering approaches, and perioperative immunotherapy strategies are highlighted in today’s podcast, which explores how these efforts are leading to evolving endpoints and access-focused oncology development.

Welcome to The BioPharm Brief, your daily snapshot of the latest developments shaping biopharmaceutical research, clinical progress, and regulatory strategy. Today’s update highlights advances in oncology across rare cancers, immunotherapy combinations, and strategic acquisitions aimed at next-generation cell therapy platforms.

New data from Immunocore reinforce the long-term clinical impact of tebentafusp in metastatic uveal melanoma, a rare and historically difficult-to-treat cancer. Five-year overall survival findings from a phase 3 trial show sustained benefit, building on earlier evidence that established tebentafusp as the first therapy to demonstrate a meaningful survival advantage in this patient population. These results highlight the growing importance of T-cell receptor–based immunotherapies in addressing tumors that have shown limited response to conventional checkpoint inhibitors.

In parallel, Eli Lilly and Company announced plans to acquire Kelonia Therapeutics to advance in vivo CAR-T cell therapies, signaling continued investment in next-generation cell engineering approaches. Unlike traditional ex vivo CAR-T therapies, in vivo strategies aim to generate engineered immune cells directly within the patient’s body, potentially simplifying manufacturing and expanding access. The move reflects broader industry efforts to improve scalability and reduce complexity in cell therapy development.

Meanwhile, FDA has granted priority review to the combination of Padcev, an antibody-drug conjugate, and Keytruda, a PD-1 inhibitor, for the treatment of muscle-invasive bladder cancer. The application is supported by phase 3 data demonstrating statistically significant improvements in event-free and overall survival, with the potential to establish a new perioperative standard of care if approved. The agency has set a target decision date of Aug. 17, 2026.

Taken together, these developments reflect a significant shift in oncology toward combination strategies, durable survival outcomes, and platform innovations designed to expand patient access to advanced therapies.

Thanks for listening to The BioPharm Brief. For analysis and expert insights, please visit BioPharmInternational.com.

Summary of key developments

  • Tebentafusp demonstrates durable 5-year survival benefit in metastatic uveal melanoma.
  • Lilly’s acquisition strategy highlights momentum in scalable in vivo CAR-T therapies.
  • FDA priority review for Padcev plus Keytruda underscores progress in bladder cancer combination treatment.

Related to this article

The BioPharm Brief: An AI-Designed Multibody ADC Enters the Clinic, Blackstone Backs Pfizer’s Monthly GLP-1, and enGene Readies a Bladder Cancer BLA
FDA clears the IND for Biolojic Design’s BD200, an AI-designed Trop2/Nectin-4 multibody ADC; Blackstone Life Sciences agrees to provide Pfizer up to $1.5 billion to develop its monthly GLP-1 receptor agonist berobenatide; and enGene Therapeutics plans a year-end BLA for detalimogene voraplasmid in BCG-unresponsive non-muscle invasive bladder cancer.
The BioPharm Brief: FDA Designations for a Bispecific CAR-T, a BLA for Friedreich’s Ataxia, and Phase 2b MASH Data for Efinopegdutide
FDA grants RMAT and Fast Track designations to AbelZeta’s CD20/CD19 bispecific CAR-T prizlon-cel in relapsed or refractory large B-cell lymphoma, Larimar Therapeutics completes a BLA seeking accelerated approval of nomlabofusp for Friedreich’s ataxia, and Merck’s GLP-1/glucagon receptor agonist efinopegdutide meets its primary endpoint in a phase 2b MASH trial.
The BioPharm Brief: argenx Bets on Peptides, a Two-Bispecific Regimen in Prostate Cancer, and a New Take on T-Cell Engagers
argenx agrees to acquire macrocyclic peptide developer Unnatural Products for up to about $1.15 billion, Johnson & Johnson’s pasritamig and JNJ-9401 bispecific regimen achieves a 73% PSA response in phase 1 in metastatic castration-resistant prostate cancer, and Janux Therapeutics’ TRBV6-targeted T-cell engager JANX011 shows deep B-cell depletion in healthy volunteers.
The BioPharm Brief: A Bispecific Approval in Head and Neck Cancer, TCR Bispecifics Head to the Clinic, and a New Antibody Target in Essential Thrombocythemia
FDA grants accelerated approval to Johnson & Johnson’s subcutaneous EGFR/MET bispecific Rybrevant Faspro for previously treated head and neck squamous cell carcinoma, T-Therapeutics raises a $133 million Series B to take TCR-CD3 bispecifics into clinical trials, and Alethio Therapeutics raises a $90 million Series A to advance its first-in-class G6B antibody for essential thrombocythemia.
The BioPharm Brief: Ivonescimab Priority Review in China, Stargardt Gene Therapy Moves Toward Phase 3, and Longer Dosing Intervals for an IBD Bispecific
China’s NMPA grants priority review to Akeso’s PD-1/VEGF bispecific ivonescimab with chemotherapy for first-line biliary tract cancer, VeonGen Therapeutics aligns with FDA on a phase 3 design for its dual-AAV Stargardt gene therapy VG801, and Caldera Therapeutics’ IL-23p19×TL1A bispecific CLD-423 shows a half-life of more than 40 days in a phase 1a trial.
The BioPharm Brief: A $7 Billion Oncology Option Deal, a TL1A Pivot, and Oral Adalimumab Heads to the Clinic
Boehringer Ingelheim licenses six preclinical ADC and T-cell engager programs from Sino Biopharmaceutical in a deal worth up to $7 billion, Spyre Therapeutics drops anti-TL1A antibody SPY072 in rheumatic diseases after phase 2 misses and turns to hidradenitis suppurativa, and Biora Therapeutics gets ethics approval for a first-in-human trial of its BioJet oral adalimumab capsule.