Anlotinib

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The APOLLO Study in China combined anlotinib (TKI) with penpulimab (anti-PD1) in advanced hepatocellular carcinoma, showing improved progression-free survival (6.9 months vs. 2.8 months) and overall survival (16.5 months vs. 13.2 months) compared to sorafenib, with manageable safety profiles. The study's results contrast with negative US trials, suggesting potential regional differences in treatment efficacy.

Benmelstobart plus anlotinib showed improved clinical outcomes for advanced RCC compared to sunitinib in the ETER100 trial, with a median PFS of 18.96 months vs 9.76 months, and ORR of 71.6% vs 25.1%. The combination reduced the risk of progression or death by 47%.

Benmelstobart plus anlotinib showed superior PFS (18.96 months vs 9.76 months) and ORR (71.6% vs 25.1%) compared to sunitinib in advanced RCC patients, with a safety profile consistent with each agent.

The Phase III APOLLO trial presented at ESMO 2024 showed Chia Tai Tianqing's Focus V (anlotinib) plus Akeso's penpulimab significantly improved progression-free survival (PFS) and overall survival (OS) in first-line advanced hepatocellular carcinoma (aHCC) compared to sorafenib, with a manageable safety profile. This contrasts with the failure of Merck's Keytruda in the LEAP-002 trial. Elevar Therapeutic's PD-1 IO camrelizumab and TKI rivoceranib also showed benefits in the CARES-310 trial but with more adverse events. Despite these results, Roche's Tecentriq with bevacizumab remains the first-line standard of care in aHCC, predicted to generate $980m in sales by 2029.

The APOLLO trial at ESMO 2024 showed Chia Tai Tianqing's Focus V and Akeso's penpulimab significantly improved PFS and OS in advanced hepatocellular carcinoma (aHCC) compared to sorafenib, with a manageable safety profile. This contrasts with the failure of Merck & Co's Keytruda in the LEAP-002 trial. Competitive IO-TKIs like Elevar Therapeutics' camrelizumab and rivoceranib also showed benefits but with more TRAEs. Roche's Tecentriq with bevacizumab remains the first-line standard-of-care in aHCC, posing a challenge to new IO-TKI combinations.

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.

Akeso, Inc. to present results from 13 clinical studies on cadonilimab, ivonescimab, ligufalimab, and penpulimab at ESMO Congress 2024, covering advanced colorectal cancer, triple-negative breast cancer, head and neck squamous cell carcinoma, hepatocellular carcinoma, nasopharyngeal carcinoma, gynecological malignancies, gastric cancer, esophageal squamous cell carcinoma, and biliary tract malignancies. Key findings include ivonescimab's efficacy in mCRC and TNBC, and a Phase III study comparing anlotinib plus penpulimab versus sorafenib for HCC.

Innovent Biologics to present nearly 20 clinical data on novel oncology molecules at WCLC and ESMO, including updated Phase 1 results of IBI363 in NSCLC and colorectal cancer, pivotal Phase 2 results of Dupert in NSCLC, and Phase 1 results of IBI354 in HER2+ solid tumors.