AMERICAN SOCIETY OF CLINICAL ONCOLOGY

Nivolumab demonstrated a significant survival benefit over docetaxel in advanced NSCLC, with 5-year OS rates of 13.4% vs 2.6% and PFS rates of 8.0% vs 0%. It maintained a favorable safety profile, with no new safety signals identified, offering durable responses and long-term survival benefits.

ASCO and Friends of Cancer Research recommend modernizing clinical trial eligibility criteria to include more patients, addressing underrepresentation and speeding trial accrual. Recommendations focus on washout periods, medications, prior therapies, lab ranges, and performance status.

Fewer cancer survivors report provider discussions on weight loss, physical activity, diet, and smoking compared to those without cancer history, despite higher health risks. The study highlights a gap in lifestyle counseling for cancer survivors, emphasizing the need for increased provider engagement in health behavior discussions.

Network meta-analysis of PARP inhibitor regimens in BRCA-mutated ovarian cancer showed no significant differences in efficacy and toxicity between upfront and relapsed settings. ASCO value framework indicated similar clinical benefits and net health benefit, with upfront regimens having lower toxicity. Adding bevacizumab to olaparib increased cost per unit net health benefit.

FDA approved pembrolizumab (Keytruda) for metastatic or recurrent head and neck cancer, improving survival rates significantly. Led by Dr. Barbara A. Burtness, a Yale-led trial showed pembrolizumab, alone or with chemotherapy, outperforms conventional treatments, especially in patients with higher PD-L1 expression. The treatment's durability and effectiveness across various subgroups highlight its potential as a first-line therapy.

Clinical trials in oncology are evolving towards adaptive, biomarker-driven designs for molecularly targeted agents and immune therapies, focusing on patient subsets. This shift aims to balance operational efficiency, scientific impact, and patient value. Key considerations include leveraging modern technologies for molecular and immune characterization, designing 'smart' trials based on big data, and incorporating patient-reported outcomes. The future of clinical trials emphasizes patient-centric approaches, data sharing, and global collaboration to address unmet needs and improve cancer care.

Eukaryotic cells repair DNA damage via mechanisms like BER, HR, and NHEJ. PARP proteins, especially PARP1, play a key role in DNA repair. PARP inhibitors, such as olaparib, niraparib, and rucaparib, show promise in treating BRCA-mutated ovarian cancer, with clinical trials demonstrating efficacy and manageable toxicity profiles.

Antibody-drug conjugates (ADCs) target tumor-specific antigens to deliver cytotoxic drugs selectively, minimizing systemic toxicity. Over 15 ADCs are in preclinical investigation for ovarian cancer, with some showing promise in early-phase trials. ADCs consist of an antibody, linker, and cytotoxic payload, targeting antigens like FRα, NaPi2B, MUC16, mesothelin, and tissue factor. Despite challenges, ADCs offer a novel therapeutic strategy with a favorable toxicity profile.

Network meta-analysis found no significant differences in efficacy and toxicity among PARPi regimens for BRCA-mutated ovarian cancer. ASCO value framework showed similar clinical benefits and toxicity, but higher costs for combined therapies. Upfront PARPi regimens are less toxic than relapse treatments. Cost-effectiveness should guide regimen choice.

Biosimilar filgrastim, a cost-effective alternative to branded filgrastim for preventing chemotherapy-induced neutropenia, has seen rapid adoption in Europe and Japan, with slower uptake in the U.S. and Canada. Marketed at significant discounts, biosimilar filgrastim aims to reduce oncology drug costs. Adoption barriers include regulatory, pricing, and substitution policies, with recommendations for improving U.S. adoption based on positive international experiences.