Memorial Sloan Kettering Cancer Center

Saad Z. Usmani discussed CEPHEUS trial results at IMS conference, highlighting quadruplet regimens for transplant-ineligible myeloma patients, comparing it to MAIA trial, and detailing medication combinations like VRd and DRd.

ImPact Biotech's Phase 3 ENLIGHTED trial for Padeliporfin VTP in low-grade UTUC achieved 50% enrollment, with full enrollment expected by Q1 2025. Interim results show 77% CR in response-evaluable patients, supported by EIC investment.

ImPact Biotech's Phase 3 ENLIGHTED trial achieved 50% enrollment for Padeliporfin VTP therapy in low-grade UTUC patients, with interim results showing 77% CR rate. The study is expected to complete enrollment by Q1 2025, supported by substantial investment from the European Innovation Council.

Immunotherapy advancements in small cell lung cancer (SCLC) include durvalumab's approval for limited-stage SCLC based on ADRIATIC trial, showing improved survival and PFS. Tarlatamab-dlle, a BiTE, received FDA approval for extended-stage SCLC. ABBV-706, an ADC, demonstrated efficacy in phase 1 study, while GSK5764227 received breakthrough designation for relapsed SCLC.

Bispecific antibodies market highlights include >30 development platforms, >USD 8B market size in 2023, and >800 clinical trials. Key approved antibodies like Blincyto and Hemlibra have seen significant sales. The market is driven by innovations in immuno-oncology, with ongoing trials by major pharma companies and research institutions globally.

FDA's ODAC voted 2 to 10 against favorable risk-benefit for CPIs in first-line HER2-negative gastric/GEJ adenocarcinoma with PD-L1 < 1. Discussions focused on data from nivolumab, pembrolizumab, and tislelizumab trials, highlighting clear benefits in PD-L1 > 10 and lack of benefit in PD-L1 < 1. FDA proposed product-specific vs. uniform PD-L1 cutoffs, considering safety and efficacy across PD-L1 strata. Clinical perspectives emphasized challenges in PD-L1 testing and the importance of patient-doctor discussions for intermediate PD-L1 values.

The FDA's ODAC voted 10-2 against PD-1 inhibitors in first-line HER2-negative, MSS gastric/GEJ adenocarcinoma with PD-L1 < 1, citing unfavorable risk:benefit. Data from CheckMate 649, KEYNOTE-859, and RATIONALE-305 trials showed OS benefits in higher PD-L1 subgroups, but not in those with PD-L1 < 1, raising concerns over toxicity and cost.

GLP-1 agonists like semaglutide and tirzepatide are increasingly used for weight loss, including in breast cancer patients. A study at Memorial Sloan Kettering Cancer Center found that these drugs led to an average 5% weight loss in breast cancer patients, with more significant losses over time. The study, presented at the 2024 ASCO Annual Meeting, aimed to assess the impact of GLP-1 agonists on weight and potential breast cancer outcomes, though no significant associations were found due to the small cohort size. The findings suggest GLP-1 agonists could be useful in managing weight gain, a common adverse event in breast cancer patients, potentially improving long-term outcomes.

MSK's immunotherapy breakthroughs, including precision vaccines, aim to harness the immune system to fight cancer. These vaccines target unique genetic signatures, enabling immune cells to attack cancer while sparing healthy cells, and can be combined with other therapies. MSK's Olayan Center for Cancer Vaccines, supported by The Olayan Charitable Foundation and others, accelerates research into treating pancreatic and other cancers.