Oncology Updates - Key Oncology News

November 3rd Week, 2025

Regulatory Events

🎯 The EC granted approval to Merck & Co./MSD's subcutaneous formulation of pembrolizumab (KEYTRUDA SC, anti-PD-1) for use across all 33 KEYTRUDA indications for adult patients in Europe. (Ref 1)

❓ What are the key pros and cons of this SC formulation?

🎯 The EC granted approval to Regeneron's cemiplimab (anti-PD-1) as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma at high risk of recurrence after surgery and radiation. (Ref 2)

❓ How is this approval expected to impact the treatment algorithm of CSCC?

🎯 The US FDA granted full approval to Amgen's tarlatamab (DLL3–targeting bispecific T-cell engager) for the treatment of adult patients with extensive stage SCLC with disease progression on or after platinum-based chemotherapy. (Ref 3)

❓ What are the clinical outcomes that support this approval?

🎯 The US FDA granted accelerated approval to Bayer's sevabertinib (kinase inhibitor) for adults with locally advanced or metastatic, non-squamous NSCLC whose tumors have HER2 TKD activating mutations, who have received a prior systemic therapy. (Ref 4)

❓ How do the outcomes of sevabertinib compare against the existing benchmarks?

Clinical Events

🔬 In the Phase 3 HERIZON-GEA-01 trial, Jazz Pharmaceuticals & Zymeworks Inc.'s zanidatamab (bispecific HER2-directed antibody) in combination with chemotherapy, with or without BeOne Medicines' tislelizumab (PD-1 inhibitor) met the PFS endpoint as a first-line treatment for HER2+ve, locally advanced or metastatic gastroesophageal adenocarcinoma, including cancers of the stomach, gastroesophageal junction, and esophagus. (Ref 5)

❓ What are the current SOC benchmarks for this indication?

Special Designations

⭐ The US FDA granted the fast track designation to Dewpoint Therapeutics' DPTX3186 (oral condensate modulator) for the treatment of gastric cancer. (Ref 6)

❓ What are the key unmet medical needs of this indication?

⭐ The US FDA granted the orphan drug designation to OBI Pharma's OBI-902 (TROP2 ADC) for the treatment of Cholangiocarcinoma. (Ref 7)

❓ Which are the other key ADCs being developed for this indication?

To know answers to these questions and for additional insights, write to us at support@oncofocus.com.

🌐 References:

1) https://www.merck.com/news/european-commission-approves-subcutaneous-administration-of-keytruda-pembrolizumab-for-all-adult-indications-approved-in-the-european-union/

2) https://investor.regeneron.com/news-releases/news-release-details/libtayor-cemiplimab-approved-european-union-first-and-only

3) https://www.amgen.com/newsroom/press-releases/2025/11/fda-grants-full-approval-to-amgens-imdelltra-in-extensive-stage-small-cell-lung-cancer

4) https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sevabertinib-non-squamous-non-small-cell-lung-cancer

5) https://ir.zymeworks.com/news-releases/news-release-details/zymeworks-announces-positive-herizon-gea-01-phase-3-results

6) https://dewpointx.com/fda-grants-fast-track-designation-to-dewpoint-therapeutics-dptx3186-for-the-treatment-of-gastric-cancer/

7) https://finance.yahoo.com/news/obi-902-granted-us-fda-120000973.html?guccounter=1&guce_referrer=aHR0cHM6Ly93d3cub25jb2xvZ3luZXdzY2VudHJhbC5jb20v&guce_referrer_sig=AQAAAGL1L_tnn0vlENE_BL12onB3mfYAAqqB73CMgEznY7Na6nPxL9ZVQZQ5-xKseuY4VUQxhkfqybpgoMKXmnsB2x4-3VUs4SBKQ9gFJYnOIHboKIJPP1hYK8DxhrVDCBUZgRlAL0AHkLtDvhtWX01HweYaQPLK4GOxwm8hPZEzhV2f