ImmunityBio said the Saudi FDA encouraged submission of a regulatory package for recombinant BCG and opened talks on expanding ANKTIVA with checkpoint inhibitors to additional tumor types. The company expects to file the rBCG package within weeks.
The SONIA trial found no overall survival benefit for first-line CDK4/6 inhibitors versus second-line use in advanced HR+/HER2- breast cancer. Median survival was 47.9 vs 48.1 months, though post hoc analysis suggested benefit in premenopausal patients. First-line treatment was associated with more severe adverse events.
Biodexa Pharmaceuticals has licensed MTX240, a Phase 1-ready molecular glue therapy for gastrointestinal stromal tumors from Otsuka. The drug demonstrated preclinical efficacy in resistant tumors and is eligible for orphan drug exclusivity, with clinical trials planned by year-end.
A Phase 3 trial shows administering immunochemotherapy before 3:00 PM improves survival outcomes in advanced NSCLC. Early treatment resulted in 11.3 months progression-free survival versus 5.7 months for late treatment, and 28.0 months overall survival versus 16.8 months. The findings suggest treatment timing is a modifiable factor that can enhance efficacy without additional cost.
The FDA has approved Optune Pax, a Tumor Treating Fields device, for use with chemotherapy in locally advanced pancreatic cancer. The approval is based on phase 3 trial data showing improved overall survival and pain progression outcomes. This marks the first new treatment approach for this patient population in approximately 30 years.
The FDA approved subcutaneous amivantamab for EGFR-mutated NSCLC in December 2025 based on phase 3 PALOMA-3 trial data showing noninferior efficacy with reduced infusion reactions and 5-minute administration time. The formulation decreases infusion-related reactions from 66% to 13% and improves patient convenience and quality of life. Recent MARIPOSA trial updates show amivantamab plus lazertinib extends median overall survival by at least 12 months versus osimertinib monotherapy.
Elicio Therapeutics granted inducement stock options to new employees, with one grant of 1,600 options at $12.16 per share and another of 30,300 options at $8.59 per share. The clinical-stage biotech company is developing novel immunotherapies targeting mKRAS-positive cancers, with its ELI-002 program showing promising Phase 1 results including 16.3-month median recurrence-free survival.
ImmunityBio resubmitted its supplemental BLA to the FDA for ANKTIVA in papillary bladder cancer after providing additional data. The company also received encouragement from Saudi regulators to submit a recombinant BCG application and expand ANKTIVA approvals.
The immuno-oncology market is projected to grow from $65.22 billion in 2025 to $170.19 billion by 2032, driven by checkpoint inhibitors, CAR-T cell therapy, and cancer vaccines, with North America commanding 43% market share.
ImmunityBio announced $113 million in net product revenue for Anktiva in 2025, a 700% year-over-year increase, while expanding regulatory authorization to 33 countries and securing first approval for lung cancer treatment in Saudi Arabia.
