AMERICAN SOCIETY OF CLINICAL ONCOLOGY

MAIA Biotechnology Inc. reports encouraging interim results from phase 2 THIO-101 trial for advanced NSCLC, showing survival benefits with 16 patients exceeding 12 months follow-up. THIO targets telomeres to induce DNA damage and cancer cell death, with plans to explore its use in other cancers like HCC, SCLC, and malignant gliomas.

FDA approval of Imdelltra (tarlatamab-dlle) in 2024 for extensive-stage small cell lung cancer (ES-SCLC) provided hope for Sabrina Potts, who experienced significant improvement after treatment. Imdelltra, a bispecific T-cell engager, forces interaction between tumor and immune cells, leading to tumor attack. Despite side effects like cytokine release syndrome and neurologic toxicity, the therapy showed a 40% objective response rate with a median duration of response of 9.7 months. Challenges in SCLC treatment include late-stage diagnosis and frequent relapse, but recent advancements like Imdelltra and Imfinzi offer new options, though a cure remains elusive.

TORL BioTherapeutics appoints Dr. Howard A. Burris III to its Board, leveraging his expertise in cancer therapy development to advance the company's ADC programs and clinical trials.

FDA's July guidance on using real-world evidence (RWE) emphasizes data provenance, patient migration documentation, and avoiding data source bias. It does not cover devices or specific study designs, and minimal changes were made from the draft. Janssen and ASCO sought clarifications on data submission and RWE vs. electronic data capture. The FDA encourages pre-submission queries and has capacity for RWD/RWE expertise. The EMA's DARWIN project supports RWE use, aiming to improve clinical trial efficiency and reduce patient burden.

MAIA Biotechnology Inc. reported positive interim survival benefits in a phase 2 study of THIO, its lead therapy for advanced non-small cell lung cancer (NSCLC). THIO-101 trial results show 12-month survival follow-ups surpassing 12 months, with interim median survival in third-line patients at 10.6 months. THIO targets telomeres, key in cancer cell survival and spread, and has shown favorable disease control and overall response rates, with plans to expand its use to other cancer types.

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.