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Onco-Summaries: Daily Oncology Updates at a Glance

Updated: May 19


15/05/2026









FDA approved ENHERTU (fam-trastuzumab deruxtecan-nxki) for the treatment of neoadjuvant and adjuvant HER2+ early breast cancer (Ref)


FDA approved ENHERTU for two new indications in HER2-positive early breast cancer:

  • Neoadjuvant use (before surgery) based on DESTINY-Breast11 trial


    • ENHERTU followed by THP achieved 67.3% pathologic complete response (pCR) vs. 56.3% with ddAC-THP (11.2% improvement, p=0.003)


  • Adjuvant use (after surgery) based on DESTINY-Breast05 trial 


    • ENHERTU reduced risk of recurrence or death by 53% vs. T-DM1 (HR 0.47, p<0.0001)

ENHERTU included in NCCN Guidelines® as a Category 1 recommended adjuvant treatment for HER2-positive early breast cancer with residual disease













UGN-103 delivers 94.5% six‑month durability in Phase 3 UTOPIA trial, with NDA submission planned for Q3 2026 to advance next‑generation RTGel therapy in recurrent LG‑IR‑NMIBC (Ref)


In the Phase 3 UTOPIA trial, UGN-103 (mitomycin intravesical solution) achieved a 94.5% six-month durability of response (DOR) in recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC), consistent with results from the pivotal ENVISION trial of ZUSDURI


UroGen plans to submit a New Drug Application (NDA) in Q3 2026, supported by FDA alignment and consistency with ZUSDURI data













In Ph3 trial, Regeneron’s fianlimab + cemiplimab showed numeric PFS gain but missed statistical significance vs pembrolizumab in advanced or metastatic Melanoma (Ref)


Regeneron’s Phase 3 melanoma trial of fianlimab (LAG‑3) + cemiplimab (PD‑1) showed a numeric PFS benefit over pembrolizumab but missed statistical significance as a first-line treatment for patients with unresectable locally advanced or metastatic Melanoma


The trial did not achieve statistical significance for progression-free survival (PFS) versus pembrolizumab monotherapy, though a numeric improvement of 5.1 months in median PFS was observed with the high-dose fianlimab combination (11.5 months vs 6.4 months)


No new safety signals were identified with the fianlimab combination


A separate Phase 3 head-to-head trial is underway comparing the high-dose fianlimab + cemiplimab combination directly against Opdualag® (nivolumab + relatlimab)

Detailed trial results will be presented at an upcoming medical meeting












CAN‑2409 shows durable, statistically significant disease‑free survival benefit in localized prostate cancer; FDA BLA planned for Q4 2026 (Ref)


Candel Therapeutics reported extended follow-up data for CAN‑2409 (aglatimagene besadenovec) in intermediate- to high-risk localized Prostate cancer


  • Disease-free survival (DFS): 39% improvement in prostate cancer–specific DFS vs placebo after median 58 months follow-up (HR 0.61; p=0.0031)


  • Intermediate-risk subgroup (85% of patients): 41% improvement in DFS (HR 0.59; p=0.0034), 90% reduction in time to metastasis, and lower metastasis rate (0.24% vs 2.35%)


  • Secondary endpoints: Favorable trends in time to biochemical failure, time to metastasis, and time to salvage therapy


The data were presented by Mark G. Garzotto, M.D., Professor of Urology and Radiation Medicine at Oregon Health & Science University, during the “Practice-changing, Paradigm-shifting Clinical Trials in Urology” oral plenary session at the American Urological Association (AUA) 2026 Annual Meeting in Washington, D.C



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