AMERICAN SOCIETY OF CLINICAL ONCOLOGY

Cancer treatment guidelines often overlook older adults, despite their higher incidence and mortality rates. Clinical trials underrepresent older participants, leading to guidelines based on younger patient data. Toxicity is more common in older patients, especially with newer drugs. Practical interventions include whole-patient assessment, proactive monitoring, dose adjustment, and palliative care, which can optimize treatment for older adults without compromising efficacy.

Durvalumab, chemotherapy, and bevacizumab followed by maintenance with olaparib, durvalumab, and bevacizumab improved progression-free survival (PFS) in patients with newly diagnosed advanced ovarian cancer without BRCA1/2 mutations, according to the phase 3 DUO-O trial. Median PFS was 45.1 months in the treatment arm versus 23.3 months in the control arm for HRD-positive disease, and 25.1 months versus 19.3 months in the intention-to-treat population.

The FDA has granted priority review to SpringWorks Therapeutics' NDA for mirdametinib, an investigational MEK inhibitor for treating NF1-PN. The European Medicines Agency also validated the MAA for the same indication. Data from the ReNeu trial showed significant reductions in PN volume and improvements in pain and quality of life. SpringWorks anticipates potential launch in early 2025.

Merck's Keytruda failed in two clinical trials for early-stage lung and skin cancer, leading to early termination. This setback impacts Merck's expansion plans for Keytruda before its patent expires in 2028, despite the drug being one of the best-selling pharmaceuticals with $14 billion in sales in the first half of 2024.

Transcenta Holding Limited announced interim results for the six months ended June 30, 2024, highlighting clinical progress with osemitamab (TST001) in G/GEJ cancer, safety and PK data consistency in U.S. and Chinese patients, collaboration with Agilent for Claudin18.2 CDx Assay, and positive results from blosozumab (TST002) SAD study for osteoporosis. The company also completed enrollment for the FIH trial of anti-GREMLIN-1 antibody TST003 and made advancements in bioprocessing technology.

FDA approves Voranigo (vorasidenib), an IDH1 and IDH2 inhibitor, for treating Grade 2 IDH-mutant glioma in patients 12+ years old post-surgery. Voranigo offers a once-daily pill for disease management, with Phase 3 INDIGO trial results showing significant progression-free survival extension and safety.

Xspray Pharma received a Complete Response Letter from the FDA for Dasynoc, a CML and ALL treatment, requesting additional info on labeling and manufacturing inspection. No new clinical studies are required, and Xspray aims to address FDA concerns promptly.

SpringWorks Therapeutics completes NDA submission to FDA for mirdametinib, an investigational MEK inhibitor for treating NF1-PN in children and adults. The submission includes data from the Phase 2b ReNeu trial, showing significant response rates, deep and durable responses, and a manageable safety profile. Mirdametinib has received Orphan Drug and Fast Track designations from the FDA and is planned for MAA submission to the EMA in the second half of 2024.

Jazz Pharmaceuticals completes BLA submission for zanidatamab, a HER2-targeted bispecific antibody, seeking accelerated approval for treatment of previously-treated HER2-positive metastatic biliary tract cancer. If approved, zanidatamab would be the first HER2-targeted treatment for this indication in the U.S. The BLA includes data from the Phase 2b HERIZON-BTC-01 trial showing a confirmed objective response rate of 41.3% in HER2-positive BTC patients, with a manageable safety profile.