Sintilimab

Sintilimab and bevacizumab combo showed 40.5% objective response rate in relapsed/persistent ovarian clear cell carcinoma patients, with manageable safety; larger trials needed.

Benmelstobart plus anlotinib demonstrated promising efficacy and low toxicity in Chinese EGFR-positive advanced NSCLC patients who progressed after EGFR TKI therapy, suggesting a potential chemotherapy-free immunotherapy option. The combination showed a mPFS of 9 months and a mOS of 28.9 months, with a DCR of 87.3% and a mDoR of 19.8 months, outperforming previous studies. The therapy's favorable safety profile and oral administration convenience highlight its potential in the evolving treatment landscape for this patient population.

Dr. Shu's phase II study in advanced hepatocellular carcinoma reports encouraging response rates and median progression-free survival with QL1706, a bifunctional antibody combining anti-PD-1 and anti-CTLA-4 with reduced toxicity. The study, involving 120 patients, compared QL1706 in various combinations, including with chemotherapy and bevacizumab, showing higher response rates than control arms. The study's relevance to patients with liver dysfunction remains unclear, but QL1706's potential to facilitate triplet combinations with less toxicity is promising.

The FDA released a draft guidance on multiregional clinical trials (MRCTs) in oncology, emphasizing that results must be interpretable to US patients. The guidance addresses issues raised during the review of Innovent Biologics and Eli Lilly’s cancer therapy Tyvyt, which was not approved in the US. The FDA advises sponsors to consider specific patient factors and socio-cultural influences, ensuring MRCT data supports a robust assessment of safety and effectiveness in US patients.

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Study evaluates PD-1 blockade efficacy and tolerability in elderly patients with metastatic esophageal squamous cell carcinoma (ESCC), finding ORR of 23.1% and median OS of 10.9 months, suggesting PD-1 blockades as a viable option for this population.

25 patients with SCLC were enrolled and treated; 60% showed partial response, 76% disease control rate. Median PFS was 6.0 months, mOS 13.4 months. 92% experienced treatment-related adverse events, most common being leukopenia, anemia, and elevated GGT. ctDNA analysis revealed frequent TP53, MUC16, RB1, DNMT3A, and ZFHX4 mutations. KMT2D mutations negatively impacted survival and treatment response. High on-treatment bTMB correlated with improved PFS and OS, suggesting it as a predictive biomarker.

OBiS Insights pre-meeting ESMO24 report profiles 275 new, unapproved cancer drugs, classified as 40% antibody-based, 37% small molecule, and 23% mixed bag. The report excludes drugs not in abstract titles and will update during the conference. 43% of these drugs were discussed at recent ASCO24 meetings.

First bispecific antibody drug conjugate expected in market by 2029; China leads in clinical trials; major focus on breast cancer; key companies involved; collaborations and licensing agreements accelerate development; regulatory approvals increasing; patent landscape complex; market growth anticipated with late-stage clinical trial results.