Onco-Summaries: Daily Oncology Updates at a Glance
17/09/2026
Phase III CELESTIMO study met its primary endpoint of PFS, with Lunsumio + lenalidomid in Follicular Lymphoma (Ref)
Roche announced positive interim results from the Phase III CELESTIMO study evaluating Lunsumio® (mosunetuzumab; CD20 x CD3 T-cell engaging bispecific antibody) + lenalidomide in patients with relapsed/refractory follicular lymphoma who had received at least one prior line of therapy
The study met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival compared with rituximab + lenalidomide. Overall survival data were immature at the time of analysis and will be evaluated in future follow-up
Additionally, regimen demonstrated a manageable safety profile consistent with the known safety of the individual assets, with no new safety signals identified
The regimen offers a chemotherapy-free treatment approach with outpatient administration and flexible intravenous or subcutaneous dosing options
The CELESTIMO trial serves as the confirmatory study intended to convert the accelerated approval/conditional marketing authorisation of Lunsumio monotherapy for third-line or later (3L+) FL to full approval, as well as to secure an indication in second-line or later (2L+) FL
Roche plans to submit the data to regulatory authorities and present detailed results at a future scientific meeting
OS Therapies announces FDA Alignment on Phase 3 Design and Project Orbis Participation for OST-HER2 in metastatic osteosarcoma (Ref)
OS Therapies announced regulatory progress for its OST-HER2 program in metastatic osteosarcoma, including incremental alignment with the FDA on the proposed adaptive Phase 3 trial design and acceptance of an invitation from the UK MHRA to participate in Project Orbis, supporting a coordinated international regulatory review strategy
FDA, MHRA, and EMA are aligned on the proposed adaptive Phase 3 study design for OST-HER2 in patients with fully resected pulmonary metastatic osteosarcoma, with trial initiation planned for Q4 2026
The company has accepted MHRA's invitation to participate in Project Orbis, which enables concurrent review of oncology products across multiple regulatory agencies
A Type B Pre-BLA meeting with the FDA is anticipated following submission of the clinical section containing 3-year overall survival data, completing the BLA package initiated earlier this year
OS Therapies continues to pursue U.S. Accelerated Approval and conditional approvals in Europe, the U.K., and Australia
OST-HER2 has received multiple regulatory designations, including Rare Pediatric Disease, Fast Track, and Orphan Drug status, and may be eligible for a Priority Review Voucher upon approval
The update builds on previously reported Phase 2b data demonstrating improvements in 12-month event-free survival and overall survival in patients with fully resected pulmonary metastatic osteosarcoma
US FDA Approves Label Update for IBTROZI (taletrectinib), with Updated Duration of Response in TKI-Naïve Advanced ROS1-Positive NSCLC (Ref)
Nuvation Bio Announces US FDA approval of a supplemental NDA for IBTROZI® (taletrectinib), resulting in a label revision that incorporates longer-term efficacy data from the TRUST clinical program in patients with advanced ROS1-positive NSCLC
The revised label includes updated duration of response (DOR) data for TKI-naïve patients and reflects extended follow-up from the pivotal studies
FDA approved the supplemental NDA approximately four months ahead of the scheduled PDUFA date
The updated label reports a median DOR of 49.7 months in TKI-naïve ROS1-positive NSCLC patients from the TRUST-I study, based on a median follow-up of 51 months
The label update incorporates an additional 14 months of follow-up from the TRUST-I and TRUST-II studies
No new safety signals were identified, and the FDA-approved label includes no changes to the existing safety information
Nuvation Bio noted that the reported 49.7-month median DOR is the longest median duration of response reported for an FDA-approved ROS1 tyrosine kinase inhibitor
Taletrectinib is currently approved in the U.S., China, and Japan, with regulatory reviews ongoing in Europe and the UK
NICE Recommends Enhertu for HER2-Low Advanced Breast Cancer (Ref)
NICE has issued final draft guidance recommending Enhertu (trastuzumab deruxtecan) for adults with HER2-low advanced or metastatic breast cancer whose disease has progressed following prior treatment
The decision enables routine NHS access for eligible patients and is expected to benefit approximately 1,000 patients annually
NICE's recommendation follows a new commercial agreement between the NHS and the manufacturers, Daiichi Sankyo and AstraZeneca, after the therapy was previously not recommended on cost-effectiveness grounds.
The reassessment was supported by NICE's updated evaluation framework, including revised cost-effectiveness considerations and methodology changes related to quality-of-life assessments.
Clinical evidence reviewed by NICE demonstrated that Enhertu improves overall survival and delays disease progression compared with standard chemotherapy in patients with HER2-low metastatic breast cancer.
NICE noted that the recommendation reflects its commitment to ensuring patient access to innovative therapies while maintaining value for NHS resources.
The guidance is currently open for appeal, with the consultation period ending on October 7, 2026
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