AMERICAN SOCIETY OF CLINICAL ONCOLOGY

The AEGEAN trial's data on perioperative durvalumab in resectable NSCLC sparked discussions on the efficacy's source, prompting the FDA's ODAC to vote for future trials to assess treatment phase contributions. Durvalumab received FDA approval for neoadjuvant and adjuvant use in resectable NSCLC, but the trial's design did not clarify the phase-specific benefits. Future trials must address potential overtreatment concerns and evaluate the optimal duration and combination of therapies.

Generic drug repurposing in oncology faces challenges due to lack of financial incentives and focus on de novo drug development. Nonprofits and non-manufacturers are advancing this field, but regulatory approval for new indications is difficult. A proposed 'labeling-only 505(b)(2) NDA' could streamline approval for non-manufacturers, increasing utilization of low-cost generics and improving patient outcomes.

Industry-sponsored cancer clinical trials in the U.S. have doubled, while federally supported trials remain flat, raising concerns over critical research gaps in cancer prevention, screening, and health disparities. Diversified funding and advocacy are needed to ensure all patient populations benefit.

PARP1-selective inhibitors, like saruparib, aim to reduce hematologic toxicity in oncology by selectively targeting PARP1, potentially improving therapeutic benefits over first-generation PARP1/2 inhibitors. Saruparib is being evaluated in the PETRA trial for advanced solid tumors and showed favorable safety and tolerability with high target pharmacokinetic coverage. The phase 3 EvoPAR-Prostate01 trial is examining saruparib in combination with next-generation hormonal agents for metastatic castration-sensitive prostate cancer.

Adcendo's ADC candidate ADCE-D01, targeting uPARAP, receives FDA IND clearance for Phase I/II trial in metastatic soft tissue sarcoma. The study aims to assess safety, tolerability, and efficacy, with plans to enroll patients in the US and Europe.

AbbVie submitted a BLA to the FDA for Teliso-V, an ADC targeting c-Met overexpression in EGFR wild-type, nonsquamous NSCLC. Data from the phase 2 LUMINOSITY trial showed ORRs of 34.6%, 22.9%, and 28.6% in c-Met high, intermediate, and overall overexpression groups, with median DORs of 9.0, 7.2, and 8.3 months, respectively. Median PFS was 5.5, 6.0, and 5.7 months, and median OS was 14.6, 14.2, and 14.5 months. No new safety signals were observed.

Studies highlight prevalence of psychiatric disorders among cancer patients, psychological distress by cancer site, and management of anxiety and depression in survivors, with a focus on screening, assessment, and care of anxiety and depressive symptoms. Emerging treatments include ketamine and psychedelics like psilocybin, which show potential for rapid symptom reduction and neuroplasticity enhancement.

Recent Phase II data from iTeos and GSK's anti-TIGIT therapy belrestotug plus anti-PD-1 Jemperli shows promising response rates in NSCLC patients, despite high-profile failures in the TIGIT space. Despite setbacks, companies like Roche and Merck continue TIGIT studies, emphasizing trial design's impact on outcomes. Insights suggest anti-TIGIT therapy may benefit patients with high CD-155 expression, potentially as combination therapy. Recent positive results from iTeos/GSK and Gilead/Arcus indicate a possible turning tide in TIGIT therapeutics.

Immune checkpoint inhibitors, CAR immune cells, natural killer cells, tumor-infiltrating lymphocytes, emerging immunotherapies, current immunotherapy in gastrointestinal malignancies, tumor-targeting bacteria, advancing clostridia, engineered Salmonella and E. coli strains, and probiotic-guided CAR-T cells are highlighted in cancer therapy research.

BioPharma Dive outlines key medical meetings in 2024-2025, focusing on Alzheimer’s, liver diseases, heart diseases, blood diseases, biopharma deals, investor-focused events, cardiology, neuroscience, cancer research, hepatology, cell and gene therapy, oncology, and diabetes.