Interim Safety Data for Lutetium Lu 177 Vipivotide Tetraxetan Retreatment in mCRPC: Johanna Enke, MD
Johanna Enke, MD, of UCLA Health, detailed interim safety data from the phase 2 Re-LuPSMA trial (NCT06288113) of lutetium Lu 177 vipivotide tetraxetan (Pluvicto) retreatment in patients with metastatic castration-resistant prostate cancer who had previously responded to the agent. Eligible patients had received 4 to 6 prior cycles, achieved a prostate-specific antigen decline of at least 50%, and subsequently experienced disease progression. Of 20 enrolled patients, 19 received at least 1 retreatment dose, with a median time from prior therapy to retreatment of 9.2 months and a median of 3 retreatment cycles. Of 165 reported adverse effects (AEs), 88 were possibly treatment related, most commonly lymphocytopenia, leukopenia, and anemia. The predefined stopping threshold of 5 treatment-related serious AEs was not reached, although 2 cases of serious anemia required hospitalization.
Ixotatug Vedotin in Heavily Pretreated Recurrent Germ Cell Tumors: Darren R. Feldman, MD
Darren R. Feldman, MD, of Memorial Sloan Kettering Cancer Center, highlighted data from the phase 1 CATALINA-1 trial (NCT05103683) of ixotatug vedotin (TORL-1-23), a claudin 6–directed antibody-drug conjugate, in patients with heavily pretreated recurrent germ cell tumors. Among the 11 patients in the cohort, 9 had received at least 3 prior lines of chemotherapy and 6 had undergone prior high-dose chemotherapy with autologous stem cell transplant. The objective response rate (ORR) was 45.5% (95% CI, 16.7-76.6), all 5 responses were partial, and the disease control rate was 72.7%. At a median follow-up of 13.8 months, the median PFS was 5.8 months (95% CI, 1.4-13.8), and 3 of the 6 patients with prior transplant responded. One patient remained in response at the March 2026 data cutoff, nearly 4 years after starting treatment, although Feldman noted that duration-of-response data were still immature.
INTerpath-001 Data for Intismeran Autogene Plus Pembrolizumab in Resected Melanoma: Georgina V. Long, AO, BSc, PhD, MBBS
Georgina V. Long, AO, BSc, PhD, MBBS, of Melanoma Institute Australia, presented findings from the phase 3 INTerpath-001 trial (NCT05933577) of adjuvant intismeran autogene (mRNA-4157; V940) plus pembrolizumab (Keytruda) in patients with resected stage IIB to IV melanoma. Overall, 1137 patients were randomly assigned 2:1 to receive intismeran plus pembrolizumab (n = 757) or placebo plus pembrolizumab (n = 380). At a median follow-up of 24.6 months, the combination reduced the risk of recurrence or death by 42% (HR, 0.58; 95% CI, 0.45-0.75; P < .001), with 24-month recurrence-free survival rates of 82.2% vs 70.0%, respectively. The combination also reduced the risk of distant metastasis or death by 38% (HR, 0.62; 95% CI, 0.45-0.85; P = .002). Intismeran did not increase immune-related AEs associated with pembrolizumab, and its toxicities were limited to transient grade 1 or 2 injection-site and vaccination-related reactions.
First-Line Amivantamab Plus Pembrolizumab and Carboplatin in HNSCC: Paul L. Swiecicki, MD
Paul L. Swiecicki, MD, of the University of Michigan Rogel Cancer Center, outlined results from cohort 5 of the phase 1b/2 OrigAMI-4 trial (NCT06385080) evaluating subcutaneous amivantamab and hyaluronidase-lpuj (Rybrevant Faspro) plus pembrolizumab and carboplatin as first-line therapy for patients with recurrent/metastatic head and neck squamous cell carcinoma. Eligible patients had not received prior PD-1/PD-L1 or EGFR inhibitors and had a PD-L1 combined positive score of at least 1. Among patients with human papillomavirus (HPV)–unrelated disease (n = 22), the confirmed ORR was 77% (95% CI, 55-92), including a complete response rate of 14%. At a median follow-up of 10.6 months, the median OS was not reached, and 77% of patients were alive at 1 year. Swiecicki noted that the phase 3 OrigAMI-5 trial (NCT07276399) was comparing subcutaneous amivantamab plus pembrolizumab and carboplatin vs carboplatin, 5-fluorouracil, and pembrolizumab in patients with HPV-unrelated disease regardless of PD-L1 status.