Onco-Summaries: Daily Oncology Updates at a Glance
- Oncofocus Team
- Jul 30
- 2 min read
28/07/2026
Ris‑Rez achieves landmark Phase III PFS benefit in relapsed osteosarcoma (Ref)
GSK's licensing partner Hansoh Pharma reported that its ARTEMIS-011 phase III trial of risvutatug rezetecan (Ris-Rez; B7-H3-targeted ADC) met the primary endpoint of progression-free survival in Chinese patients with relapsed osteosarcoma
Trial design: ARTEMIS-011 evaluated Ris-Rez vs chemotherapy in osteosarcoma patients who had relapsed after at least two prior treatment lines
Results: The trial showed statistically significant, clinically meaningful improvement in progression-free survival, with consistent benefit on secondary endpoints including overall survival; safety was consistent with prior findings and no new safety signals emerged
Hansoh will use this data for a regulatory submission in China
Ris-Rez has US FDA Breakthrough Therapy Designation for relapsed/refractory osteosarcoma
FDA clears path for registrational Phase 2 of CLN-049 in AML (Ref)
Cullinan received positive feedback from the FDA in its End-of-Phase 1 meeting for CLN-049, a FLT3xCD3 bispecific T cell engager for acute myeloid leukemia (AML)
The company will initiate a potentially registrational Phase 2 trial in relapsed/refractory AML patients in Q3 2026, with a short dose-optimization phase followed by a single-arm cohort.
CLN-049 showed promising activity and favorable safety in Phase 1 study. An update from dose escalation is expected in Q4 2026
A Phase 1/2 trial will also begin, evaluating CLN-049 with venetoclax + azacitidine in previously untreated AML (NCT07722767)
CLN-049 has Orphan Drug and Fast Track designations from the FDA for relapsed/refractory AML
Insilico Medicine's ISM6331 Earns US FDA Fast Track Designation for Advanced Mesothelioma (Ref)
Insilico Medicine announced that its AI-designed pan-TEAD inhibitor ISM6331 received US FDA Fast Track Designation for the treatment of adult patients with unresectable malignant pleural mesothelioma whose disease has progressed on or after prior treatment with anti-PD-1 antibody therapy, with or without anti-CTLA-4 antibody therapy, and platinum-based chemotherapy
ISM6331 already held Orphan Drug Designation (granted June 2024) for the same mesothelioma indication
Clinical Development
Phase I trial: First patient dosed in Jan 2025; early data accepted for oral presentation at ESMO 2026
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