AMERICAN SOCIETY OF CLINICAL ONCOLOGY

Dizal submitted an NDA to the FDA for sunvozertinib, the first oral drug for NSCLC patients with EGFR exon20ins, supported by the WU-KONG1 Part B study results presented at the 2024 ASCO Annual Meeting.

Dizal submits NDA to FDA for sunvozertinib, an oral drug for relapsed or refractory NSCLC with EGFR exon 20 insertion mutations, supported by WU-KONG1 Part B study data presented at 2024 ASCO Annual Meeting.

Dizal submitted an NDA to the FDA for sunvozertinib, seeking approval for treating advanced NSCLC with EGFR exon20ins, supported by the WU-KONG1 study results.

New guidelines for AI use in brain cancer diagnosis and treatment ensure reliable clinical trial results and patient protection, addressing variability in radiologist interpretations and promoting objective AI analysis of tumor images.

Iovance Biotherapeutics reports $58.6M in 3Q24 product revenue for Amtagvi™ (Lifileucel), reaffirming $160-$165M FY24 and $450-$475M FY25 guidance. European regulatory authorities validate and accept marketing authorization applications for potential approval starting in 1H2025 for the UK and 2H2025 for EU and Canada. Enrollment accelerates in IOV-LUN-202 Phase 2 trial in post-anti-PD-1 NSCLC.

Lung cancer is the leading cause of cancer deaths in both men and women. Kiromic BioPharma’s Deltacel shows disease stabilization in NSCLC patients. Achilles Therapeutics advances EHC in phase 1/2 trials for NSCLC and melanoma. Genprex reports positive results in 2 lung cancer trials for Reqorsa but drops Acclaim-2. CAN-2409 improves survival in NSCLC patients not responding to ICI therapy.

Verastem Oncology completed NDA submission for avutometinib and defactinib in KRAS mutant low-grade serous ovarian cancer, seeking accelerated approval and priority review. Positive safety and efficacy results from the RAMP 201 trial were presented at IGCS 2024. The company anticipates an FDA decision on the NDA by mid-2025 and is preparing for a potential U.S. launch.

CytoDyn finalized a phase 2 study protocol for leronlimab in relapsed/refractory microsatellite stable colorectal cancer, gaining FDA clearance. The trial, in partnership with Syneos Health, is set to start in November 2024, with patient enrollment in early 2025. Leronlimab, combined with TAS-102 and bevacizumab, targets CCR5+ MSS mCRC patients who have undergone multiple treatments.

Despite growth in women entering U.S. medical schools, representation in academic medicine and leadership remains low, particularly in hematology/oncology. Slow improvements are seen, with only 9 out of 59 ASCO presidents being women, and few women on major medical journal editorial boards. Flexible work arrangements and targeted recruitment are suggested to address this disparity.