Onco-Summaries: Daily Oncology Updates at a Glance
15/10/2026
US FDA grants second Fast Track Designation to Invikafusp Alfa in checkpoint-refractory TMB-High solid tumors (Ref)
Marengo Therapeutics announced that the US FDA has granted a second Fast Track Designation (FTD) to Invikafusp alfa (STAR0602; bispecific dual T-cell agonist) for the treatment of tumor mutational burden-high (TMB-H) solid tumors that have progressed following prior therapies, including checkpoint inhibitors, and have limited treatment options
This designation expands the program into a tissue-agnostic setting beyond its previously granted FTD in TMB-H colorectal cancer
The designation is supported by encouraging clinical activity observed across multiple tumor types in the ongoing Phase 1/2 STARt-001 study, including colorectal, gastric, breast, urothelial, endometrial, gastroesophageal, head and neck, and lung cancers
The STARt-001 study is evaluating the agent in advanced solid tumors that are resistant or refractory to PD-1-directed therapies, with biomarker-enriched cohorts focused on TMB-H and MSI-H populations
Updated Phase 2 data from STARt-001 are scheduled for presentation in an oral session at ESMO 2026 on October 23
Revolution Medicines' RASONQUE receives positive CHMP opinion for Metastatic Pancreatic Cancer (Ref)
Revolution Medicines announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorization for RASONQUE™ (daraxonrasib) as a monotherapy for adults with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC)
If approved by the European Commission, RASONQUE could become the first broadly applicable RAS-targeted therapy for this patient population in the EU
Parameter | Daraxonrasib | Investigator's Choice Chemotherapy | Analysis / Interpretation |
Overall Survival | 13.2 months | 6.7 months | 6.5-month absolute OS improvement; 60% reduction in risk of death (HR 0.40) |
Progression-Free Survival (PFS) | 7.2 months | 3.6 months | PFS doubled; 51% reduction in risk of progression/death (HR 0.49) |
Clinical Benefit by Mutation Status | Benefit observed irrespective of RAS mutation status | N/A | Suggests potential utility across a broad PDAC population |
Regulatory Status (US) | FDA approved (Aug 2026) | N/A | Provides validation of efficacy and safety package |
Safety | Diarrhea, acneiform dermatitis, stomatitis, nausea, vomiting, fatigue most commonly reported | NA | Safety considered manageable and consistent with known profile |
The application was reviewed under the EMA's Cancer Medicines Pathfinder program, which aims to expedite assessment of medicines addressing significant unmet medical needs.
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