Oncology Video Recap—November 10, 2025

This biweekly edition spotlights the most important trends driving the future of oncology, covering science, industry, and regulatory milestones.

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Week 26 October– 2 November 2025
Week 2–9 November 2025

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Transcript

Welcome to the latest edition of Oncology Updates, covering breakthroughs in the past two weeks. Brought to you by LucidQuest.

Merck has achieved a significant milestone as the European Commission approved Keytruda, or pembrolizumab, for resectable, PD-L1–positive locally advanced head and neck squamous cell carcinoma. The approval is based on the KEYNOTE-689 trial involving 714 patients, showing a 30 percent improvement in event-free survival with a hazard ratio of 0.70. This marks the first anti–PD-1 regimen approved in the European Union for resectable head and neck cancer expressing PD-L1 with a combined positive score of one or higher.

In the United States, Cellectar Biosciences has received the FDA’s Rare Pediatric Disease Designation for iopofosine I-131 in pediatric high-grade glioma. The Phase 1b CLOVER-2 study demonstrated extended progression-free and overall survival with a favorable safety profile. The designation enables potential receipt of a priority review voucher upon approval, strengthening Cellectar’s pediatric oncology portfolio.

A2 Biotherapeutics reported the first complete response to CAR-T-cell therapy in non-small cell lung cancer. The EVEREST-2 Phase 1 Phase 2 study evaluated A2B694, a logic-gated CAR-T-cell therapy, in nine solid tumor patients. One patient with NSCLC achieved a complete response with no dose-limiting toxicities observed. This milestone highlights the emerging potential of logic-gated CAR-T platforms in solid tumors.

In China, Akeso received its fourth Breakthrough Therapy Designation from the Center for Drug Evaluation for ivonescimab in combination with chemotherapy in first-line triple-negative breast cancer. The bispecific PD-1 and VEGF antibody continues to expand its footprint, with the HARMONi-BC1 Phase 3 trial currently underway. This marks Akeso’s fourth breakthrough designation across multiple tumor types, reinforcing its leadership in bispecific immunotherapy development.

Gilead Sciences announced results from the ASCENT-07 Phase 3 study of Trodelvy in HR-positive, her 2 -negative metastatic breast cancer. The trial compared Trodelvy against chemotherapy in 654 patients and did not meet its primary endpoint of progression-free survival. However, an early overall survival trend favors Trodelvy, with data maturation ongoing.

Daiichi Sankyo and AstraZeneca’s Enhertu gained Health Canada approval as the first her 2 -directed therapy for hormone receptor–positive, her 2-low or ultralow metastatic breast cancer after progression on endocrine therapy. The DESTINY-Breast06 trial, with 866 participants, showed Enhertu reduced the risk of progression or death by 36 percent compared to chemotherapy, with a hazard ratio of 0.64 and a p-value less than 0.0001.

In another Canadian development, AbbVi’s Elahere received a positive reimbursement recommendation from Canada’s Drug Agency and the Agency for Medicines and Technologies in Health under the Target Zero program. This decision enables access to Elahere for patients with FRα-positive platinum-resistant ovarian cancer, marking the first new reimbursable option in more than ten years. The move is expected to influence pricing and formulary competition in ovarian cancer care.

Relmada Therapeutics reported that the FDA has endorsed two registrational Phase 3 study paths for NDV-01 in non-muscle invasive bladder cancer. Following a Type B pre-IND meeting, the agency confirmed that no additional non-clinical data are required. The proposed pathways include a single-arm study for refractory BCG-unresponsive patients and a randomized controlled trial for those with intermediate-risk disease.

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Why It Matters

Regulatory acceleration: Multiple designations (BTD, RPDD) show agencies’ focus on expedited oncology development.
ADC leadership: Enhertu, Elahere, and Trodelvy updates underscore rapid evolution in antibody-drug conjugate strategy.
Immunotherapy breadth: Keytruda and ivonescimab approvals widen PD-1 and bispecific use across tumor types.
Cell therapy frontier: A2 Bio’s solid-tumor CAR T response marks a milestone for logic-gated approaches.
Cross-border access: Canada emerging as early adopter for HER2-low and FRα-positive cancers.

🗓️ Explore weekly details and sources

Week 26 October– 2 November 2025
Week 2–9 November 2025

📚 See the full Oncology archive on our research hub page.

FAQ

What differentiates Merck’s new Keytruda approval?

It is the first anti-PD-1 therapy approved in the EU for resectable locally advanced HNSCC expressing PD-L1 ≥ 1 (CPS).

How could Cellectar’s RPDD benefit the company?

The FDA designation enables potential receipt or sale of a Priority Review Voucher upon approval.

Why is A2 Bio’s EVEREST-2 finding significant?

It marks the first reported complete response to CAR T-cell therapy in a non-small cell lung cancer patient.

What is ivonescimab’s clinical scope?

Akeso’s PD-1/VEGF bispecific spans lung, breast, and colorectal cancers with 14 Phase 3 trials worldwide.

Why did Gilead’s ASCENT-07 miss PFS?

While Trodelvy underperformed versus chemotherapy on PFS, an early OS trend suggests potential benefit pending maturity.

What makes Enhertu’s Canadian approval notable?

It is the first HER2-directed therapy for HR-positive HER2-low or ultralow metastatic breast cancer.

What is the status of Elahere access in Canada?

CDA-AMC recommended reimbursement with conditions, expediting patient access via Target Zero.

How is Relmada advancing NDV-01?

The FDA accepted dual Phase 3 paths for NMIBC with no new non-clinical data required.

Entities / Keywords

Keytruda (pembrolizumab) • Merck • HNSCC • iopofosine I-131 • Cellectar • A2 Biotherapeutics • A2B694 • CAR T • Akeso • ivonescimab • Gilead • Trodelvy • Enhertu (trastuzumab deruxtecan) • Daiichi Sankyo • AstraZeneca • Elahere (mirvetuximab soravtansine) • AbbVie • Relmada Therapeutics • NDV-01 • non-muscle invasive bladder cancer • regulatory approvals • ADC • PD-1 • bispecific antibody • Breakthrough Therapy Designation