FDA Approval of Enfortumab Vedotin Plus Pembrolizumab for Cisplatin-Ineligible MIBC: Christof Vulsteke, MD, PhD
Christof Vulsteke, MD, PhD, of the Integrated Cancer Center Ghent, shed light on the FDA approval of enfortumab vedotin-ejfv (Padcev) plus pembrolizumab (Keytruda) for use in patients with cisplatin-ineligible muscle-invasive bladder cancer. He noted that the regulatory decision was supported by findings from the phase 3 KEYNOTE-905 trial (NCT03924895), which addressed a major unmet need for patients unable to receive cisplatin-based chemotherapy. He explained that this combination leverages complementary mechanisms and should be considered for all eligible patients when available. Vulsteke also pointed to emerging signals suggesting potential benefit beyond cisplatin-ineligible populations, pending longer follow-up and broader regulatory access.
3-Year Data for Perioperative Toripalimab/Chemo in Gastric/GEJ Cancer: Shuqiang Yuan, MD, PhD
Shuqiang Yuan, MD, PhD, of Sun Yat-Sen University Cancer Center, unpacked 3-year follow-up data from the phase 2 NEOSUMMIT-01 trial (NCT04250948) examining perioperative toripalimab-tpzi (Loqtorzi) plus chemotherapy in patients with locally advanced gastric or gastroesophageal cancer. Data reported at the 2026 Gastrointestinal Cancers Symposium (ASCO GI) indicated that the toripalimab regimen significantly improved event-free survival and overall survival (OS) vs chemotherapy alone. These benefits were maintained in those with mismatch repair–proficient disease, supporting the broad applicability of the regimen. Yuan also added that there was a meaningful reduction in peritoneal metastasis with the toripalimab combination.
Real-World Performance of SKY92 Gene Expression Profiling for Risk Stratification in Multiple Myeloma: Noa Biran, MD
Noa Biran, MD, of Hackensack Meridian Health John Theurer Cancer Center, reported data from the prospective PROMMIS study (NCT02911571) examining the SKY92 gene expression profiling assay in multiple myeloma. She explained that approximately 30% of patients had discordant risk assignment between SKY92 and International Myeloma Society (IMS) criteria. Importantly, patients identified as high risk by SKY92 experienced poor outcomes irrespective of their IMS-defined risk category. Biran underscored that SKY92 appears to capture aggressive disease biology not consistently identified by conventional risk stratification.
Key Data for Zanidatamab-Based Combos in HER2+ Gastroesophageal Adenocarcinoma: Elena Elimova, MD
Elena Elimova, MD, of the University of Toronto and Princess Margaret Hospital, spotlighted interim findings from the phase 3 HERIZON-GEA-01 trial (NCT05152147) in patients with HER2-positive gastroesophageal adenocarcinoma. Data shared during ASCO GI showed that zanidatamab-hrii (Ziihera) plus chemotherapy, with or without tislelizumab (Tevimbra), significantly improved progression-free survival (PFS) vs trastuzumab (Herceptin) plus chemotherapy. Specifically, the median PFS exceeded 12 months in both zanidatamab arms, a milestone not previously reported in this disease. Elimova also noted improvements in OS, with zanidatamab-based combinations prolonging median survival by more than 7 months vs trastuzumab.