Oncology Updates - Key Oncology News
- Oncofocus Team
- Aug 13
- 2 min read
July 5th Week, 2026
Regulatory Events
🎯 Marketing Authorization Application (MAA) for Philogen S.p.A. and SUN PHARMA’s daromun (Nidlegy™; L19IL2 and L19TNF combination) for the neoadjuvant Tx of locally advanced, fully resectable melanoma was resubmitted to the EMA (Ref)
❓ What are the clinical benchmarks for resectable melanoma Tx in the EU?
🎯 Replimune announced a favorable outcome from the US FDA's Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) meeting to review the BLA resubmission for vusolimogene oderparepvec (RP1; oncolytic immunotherapy) + nivolumab in advanced melanoma patients who progressed on prior anti-PD-1 therapy (Ref)
❓ What were the clinical outcomes from RP1’s POC trial?
Special Designation
⭐The US FDA granted RMAT and Fast Track designations to Allogene Therapeutics' cemacabtagene ansegedleucel (cema-cel; allogeneic anti-CD19 CAR-T) for consolidation therapy for adults with large B-cell lymphoma (LBCL) who test positive for MRD post 1L Tx. (Ref)
❓ What is the current SOC for 1L LBCL?
⭐ US FDA Orphan Drug designation was granted to Sumitomo Corporation Pharma's enzomenib (DSP-5336; menin-KMT2A interaction inhibitor) for the Tx of acute lymphoblastic leukemia (ALL) (Ref)
❓ How is enzomenib positioned in the ALL landscape?
⭐ The US FDA granted a Fast Track designation to Insilico Medicine's ISM6331 (novel pan-TEAD inhibitor) for the Tx of adults with unresectable malignant pleural mesothelioma with disease progression on or after prior anti-PD-1 therapy ± anti-CTLA-4 therapy, and platinum-based chemo (Ref)
❓ Which are the key assets in the current mesothelioma landscape?
Clinical Events
🔬 GSK's licensing partner Jiangsu Hansoh Pharmaceutical Group Co., Ltd. reported that the Ph3 ARTEMIS-011 trial of risvutatug rezetecan (Ris-Rez; B7-H3-targeted ADC) met the primary endpoint of PFS in Chinese patients with ≥3L osteosarcoma (Ref)
❓ How is Ris-Rez positioned in the global osteosarcoma developmental landscape?
🔬 The Ph3 CLARITY-Gastric01 trial of AstraZeneca’s sonesitatug vedotin (Sone-Ve; CLDN18.2 targeting ADC) vs investigator’s choice of therapy in LA/M GEJ/GC or esophageal adenocarcinoma with CLDN18.2 ≥25% TC met key secondary endpoint of OS improvement in ≥2L gastric cancer patients (Ref)
❓ How is Sone-Ve positioned in the GEJ/GC developmental landscape?
To know answers to these questions and for additional insights, write to us at support@oncofocus.com.
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