Oncology Updates - Key Oncology News

November 4th Week, 2025

Regulatory Events

🎯 The EC granted approval to Bristol Myers Squibb's lisocabtagene maraleucel (anti-CD19 CAR-T) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy including a BTK inhibitor. (Ref 1)

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

🎯 The US FDA granted approval to AstraZeneca’s neoadjuvant durvalumab (anti-PD-L1) + chemotherapy followed by adjuvant durvalumab + chemotherapy, then durvalumab mono for the treatment of adult patients with resectable, early-stage and locally advanced gastric and gastroesophageal junction cancers. (Ref 2)

❓ What were the clinical outcomes that supported this approval?

🎯 The EC granted approval to CStone Pharmaceuticals' sugemalimab (anti-PD-L1) mono for adult patients with unresectable stage III NSCLC with PD-L1 ≥1% and no sensitising EGFR mutations, or ALK, ROS1 genomic aberrations and whose disease has not progressed following platinum-based chemoradiotherapy. (Ref 3)

❓ How do the outcomes of this therapy compare against the current benchmarks?

Clinical Events

🔬 The Phase 3 JS001sc-002-III-NSCLC trial of Shanghai Junshi Biosciences Co Ltd's toripalimab subcutaneous injection (anti-PD-1) + chemotherapy met its primary endpoints for the first-line treatment of recurrent or metastatic non-squamous NSCLC. (Ref 4)

❓ What are the key pros and cons of subcutaneous checkpoint inhibitors?

🔬 In the Phase 3 OptiTROP-Lung05 trial, Merck & Co./MSD and Kelun-Biotech's sacituzumab tirumotecan (TROP2 ADC) + pembrolizumab demonstrated a statistically significant and clinically meaningful improvement in PFS as a first-line treatment for PD-L1 ≥1% advanced NSCLC. (Ref 5)

❓ Which are the other key TROP2 ADC regimens being evaluated for this indication?

Special Designations

⭐ The US FDA granted priority review status to BeOne Medicines' NDA for sonrotoclax (BCL2 inhibitor) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma following treatment with a BTK inhibitor. (Ref 6)

❓ What are the launch timeline estimates for this asset?

⭐ The US FDA granted the fast track designation to Avenzo Therapeutics' AVZO-103 (Nectin4/TROP2 bispecific ADC) for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received enfortumab vedotin. (Ref 7)

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

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

🌐 References:

1) https://news.bms.com/news/corporate-financial/2025/Bristol-Myers-Squibb-Receives-Approval-from-the-European-Commission-to-Expand-Use-of-CAR-T-Cell-Therapy-Breyanzi-for-Relapsed-or-Refractory-Mantle-Cell-Lymphoma/default.aspx

2) https://www.astrazeneca.com/media-centre/press-releases/2025/imfinzi-approved-in-the-us-as-first-and-only-perioperative-immunotherapy-for-patients-with-early-gastric-and-gastroesophageal-cancers.html

3) https://www.cstonepharma.com/en/html/news/3846.html

4) https://www.globenewswire.com/news-release/2025/11/25/3193998/0/en/Junshi-Biosciences-Announces-Primary-Endpoints-Met-in-JS001sc-s-Phase-3-Study-for-the-1ST-line-Treatment-of-NSQ-NSCLC.html

5) https://www.prnewswire.com/news-releases/kelun-biotech-announces-phase-iii-trial-of-sac-tmt-in-combination-with-keytruda-pembrolizumab-as-first-line-treatment-for-pd-l1-positive-nsclc-met-primary-endpoint-302624279.html

6) https://www.businesswire.com/news/home/20251126490630/en/U.S.-FDA-Grants-Priority-Review-to-Sonrotoclax-for-the-Treatment-of-Relapsed-or-Refractory-Mantle-Cell-Lymphoma

7) https://avenzotx.com/press-releases/avenzo-therapeutics-granted-fast-track-designation-for-avzo-103-a-potential-best-in-class-nectin4-trop2-bispecific-antibody-drug-conjugate-for-the-treatment-of-patients-with-urothelial-cancer-previo/