AMERICAN SOCIETY OF CLINICAL ONCOLOGY

The phase 3 ENLIGHTED trial has reached 50% enrollment, with interim data showing 77% complete response in low-grade UTUC patients treated with padeliporfin VTP therapy. The trial aims to enroll 100 patients across 29 sites, with full enrollment expected by Q1 2025. The therapy involves intravenous padeliporfin and laser fiber illumination, with common AEs being mild and resolving quickly. The study's primary objective is to assess efficacy and durability, with secondary objectives focusing on safety and tolerability.

Johnson & Johnson's RedirecTT-1 study shows high response rates and durable responses with Talvey and Tecvayli bispecific antibody combination in relapsed or refractory multiple myeloma patients, including those with extramedullary disease, with a consistent safety profile. The overall response rate was 79.5%, with a complete response or better rate of 52.3%.

LEANORA (NCT04657679) was a prospective, observational, multicenter cohort study assessing ribociclib's pharmacokinetics and pharmacogenomics in HR+/HER2− metastatic breast cancer patients. Enrolled women self-identified as NHW or African American/Black, with ovarian suppression for premenopausal patients. The study initially planned two cohorts but closed the NHW cohort due to low enrollment. Pharmacokinetic and pharmacogenetic testing, including CYP3A5 genotyping, was conducted. Primary endpoints were ribociclib AUCtau and CYP3A5 PM vs. IM/NM, with secondary endpoints including pharmacokinetic properties and adverse events. Statistical analysis included Wilcoxon rank-sum test and exploratory candidate gene analysis for ribociclib pharmacokinetics.

ImPact Biotech announces 50% enrollment in Phase 3 ENLIGHTED trial for Padeliporfin VTP in low-grade UTUC, anticipating full enrollment by Q1 2025. Interim results show 77% CR rate, with additional data expected in Q4 2024.

AbbVie seeks FDA accelerated approval for Teliso-V, targeting c-Met overexpressing NSCLC patients with limited treatment options. Supported by Phase 2 LUMINOSITY trial data, Teliso-V aims to address unmet medical needs in NSCLC, a leading cause of cancer deaths. Phase 3 TeliMET NSCLC-01 study further evaluates its efficacy.

AbbVie submitted a Biologics License Application for Teliso-V, a first-in-class ADC targeting c-Met overexpressing NSCLC, based on Phase 2 LUMINOSITY trial data. If approved, it would address unmet needs in NSCLC treatment, offering hope for patients with poor prognosis.

AbbVie submits BLA to FDA for Teliso-V, an ADC targeting c-Met overexpressing NSCLC, supported by Phase 2 LUMINOSITY trial data. If approved, Teliso-V would be the first-in-class therapy for this patient population.

T_H 17 cells may predict irAEs in metastatic melanoma patients on nivolumab, ipilimumab, and tocilizumab. IL-6 receptor blockade with tocilizumab preserved PFS and overall survival, reducing irAEs. High IL-6 and osteopontin levels at baseline correlated with shorter survival. Treg cells increased post-immunotherapy. Tocilizumab reduced severe irAEs like colitis, myocarditis, and type 1 diabetes.

Talquetamab, a bispecific GPRC5D-directed CD3 T-cell engager, demonstrated durable responses in multiple myeloma patients with 4-5 prior therapies in TRIMM-2 and RedirecTT trials. Updated phase 1b results showed an 81.8% ORR and 15.5-month median PFS in the TRIMM-2 triplet arm, and a 79.5% ORR at 18 months in the RedirecTT-1 dual bispecific arm. Both combinations showed robust durability and efficacy, even in high-risk patients with extramedullary disease.

Olomorasib (50 or 100 mg) plus pembrolizumab showed 77% ORR in KRAS G12C-mutated metastatic NSCLC, regardless of PD-L1 expression, in the phase 1/2 LOXO-RAS-20001 study. Median time to response was 1.4 months, with 88% and 81% disease control rates in respective cohorts. AEs included diarrhea, fatigue, and increased ALT levels. A global registrational trial, SUNRAY-01, is ongoing.