Company Product Description Indication Status Date
Akeso Inc., of Hong Kong Cadonilimab PD-1/CTLA4 bispecific antibody Advanced hepatocellular carcinoma Phase Ib/II results showed 6-mg/kg Q2W dose in combination with Lenvima (lenvatinib, Eisai Ltd./Merck & Co. Inc.) as first-line treatment resulted in objective response rate (ORR) of 35.5%, median duration of response (mDoR) of 13.6 months, median progression-free survival (mPFS) of 8.61 months and median overall survival (mOS) of 27.1 months; at 15-mg/kg Q3W dose, ORR was 35.7%, mDoR was 13.7 months, mPFS was 9.82 months and mOS was not yet reached 10/25/2023
Astrazeneca plc, of London, and Daiichi Sankyo Co. Ltd., of Tokyo Dato-Dxd (datopotamab deruxtecan) Engineered TROP2-directed DXd antibody-drug conjugate Advanced or metastatic triple-negative breast cancer Phase Ib/II Begonia data of Dato-Dxd plus Imfinzi (durvalumab) demonstrated durable tumor responses and no new safety signals in patients with previously untreated disease; confirmed objective response rate of 79%, with 6 complete responses and 43 partial responses; median progression-free survival was 13.8 months and median duration of response was 15.5 months 10/24/2023
Astrazeneca plc, of London, and Daiichi Sankyo Co. Ltd., of Tokyo Datopotamab deruxtecan TROP2-directed DXd antibody-drug conjugate Locally advanced or metastatic non-small-cell lung cancer Results from Tropion-Lung01 phase III trial showed drug reduced risk of disease progression or death by 25% in overall population and by 37% in patients with nonsquamous tumors; median progression-free survival was 4.4 months vs. 3.7 for docetaxel, and results also showed a confirmed objective response rate (ORR) of 26.4% in patients treated with datopotamab deruxtecan compared to an ORR of 12.8% with docetaxel 10/25/2023
Astrazeneca plc, of London, and Daiichi Sankyo Co. Ltd., of Tokyo Datopotamab deruxtecan TROP2-directed DXd antibody-drug conjugate Inoperable or metastatic HR-positive, HER2-low or negative breast cancer Data from Tropion-Breast01 phase III trial, in patients previously treated with endocrine-based therapy and at least 1 systemic therapy, showed drug reduced risk of disease progression or death by 37%, providing a 2-month median progression-free survival benefit; confirmed objective response rate (ORR) of 36.4% in patients treated with datopotamab deruxtecan compared to ORR of 22.9% with chemotherapy; for the dual primary endpoint of overall survival, interim results numerically favored datopotamab deruxtecan over chemotherapy but did not reach statistical significance at the time of data cut-off; well-tolerated in post-endocrine therapy setting 10/25/2023
Astrazeneca plc, of London, and Daiichi Sankyo Co. Ltd., of Tokyo Enhertu (trastuzumab deruxtecan) HER2-directed antibody-drug conjugate HER2-expressing solid tumors Results from Destiny-PanTumor02 phase II trial, showed a median progression-free survival of 6.9 months and median overall survival of 13.4 months in overall trial population in advanced solid tumors, including either biliary tract, bladder, cervical, endometrial, ovarian, pancreatic cancers or other tumors; drug also continued to show confirmed objective response rate of 37.1% and median duration of response of 11.3 months in these patients 10/25/2023
Avistone Biotechnology Co. Ltd., of Beijing Vebreltinib Selective c-MET inhibitor Advanced non-small-cell lung cancer harboring MET alterations Preliminary data from phase II Kunpeng study showed primary endpoint of objective response rate (ORR) was 75%, with 39 participants achieving a complete response (CR) or partial response (PR); treatment-naïve and previously treated patients displayed an ORR of 77.1% and 70.6%, respectively; median progression-free survival was 14.1 months and median overall survival was 20.7 months 10/25/2023
Daiichi Sankyo Co. Ltd., of Tokyo, and Merck & Co. Inc., of Rahway, N.J. R-DXd (raludotatug deruxtecan) CDH6 directed DXd antibody-drug conjugate Platinum-resistant advanced ovarian cancer Phase I data showed a confirmed objective response rate of 46% in the subgroup of 50 patients with measurable ovarian cancer receiving 4.8- to 8-mg/kg doses; 1 complete response, 22 partial responses and 4 unconfirmed responses; disease control rate was 98%; median duration of response was 11.2 months; median progression-free survival was 7.9 months as of July 14, 2023 10/24/2023
Dizal Pharmaceutical Co. Ltd., of Shanghai Sunvozertinib Irreversible EGFR inhibitor Advanced or metastatic non-small-cell lung cancer with EGFR exon 20 insertion mutations Phase I/II and phase II pooled analysis showed a confirmed objective response rate of 78.6% in first-line patients; median progression-free survival was 12.4 months at the recommended phase II dose of 300 mg; well-tolerated; safety profile consistent with previous reports 10/24/2023
Hummingbird Bioscience Pte Ltd., of London and Singapore HMBD-001 Anti-HER3 antibody Tumors where HER3 plays a role Data from dose-escalation portion of phase I/IIa trial testing monotherapy showed no dose-limiting toxicities and no treatment discontinuations due to related adverse events; of 21 evaluable patients, disease control rate was 43% (9/21), with 1 patient achieving partial response with a 51% tumor shrinkage after 4 cycles of treatment 10/24/2023
Immuneoncia Therapeutics Inc., of Seoul, South Korea IMC-002 CD47 monoclonal antibody Solid tumors Phase Ia data from 12 patients enrolled in 4 dose cohorts (5 mg/kg, 10 mg/kg, 20 mg/kg or 30 mg/kg every 2 weeks) showed no dose-limiting toxicities and identified 20-mg/kg as recommended phase II dose; 6 of 11 evaluable patients with measurable lesions demonstrated stable disease (5 with liver cancer and 1 with breast cancer) 10/24/2023
Immutep Ltd., of Sydney Eftilagimod alpha Soluble LAG-3 protein and MHC class II agonist Metastatic or advanced nonsquamous non-small-cell lung cancer Data from Insight-003 trial testing combination with Keytruda (pembrolizumab, Merck & Co. Inc.) and doublet chemotherapy (carboplatin/pemetrexed) as front-line therapy showed median overall survival (OS) not reached; median progression-free survival (PFS) was 10.1 months; the combination achieved 71.4% overall response rate, 90.5% disease control rate and showed positive early trends in 12-month OS and PFS 10/25/2023
Kazia Therapeutics Ltd., of Sydney EVT-801 Small-molecule inhibitor of VEGFR3 Advanced solid tumors Data from ongoing phase I trial from analysis of biopsies from 6 high-grade serous ovarian cancer patients showed high levels of VEGFR3 expression tended to be correlated with higher levels of hypoxia and increased immune checkpoint resistance, while negatively correlated with CD8-positive T cells infiltration, suggesting those patients may benefit from EVT-801 treatment 10/24/2023
Transcenta Holding Ltd., of Suzhou, China Osemitamab (TST-001) High-affinity humanized ADCC-enhanced anti-Claudin18.2 monoclonal antibody First-line treatment of advanced gastroesophageal junction adenocarcinoma Updated efficacy data from the expansion cohort of the TranStar102 of osemitamab plus CAPOX chemotherapy study continued to show efficacy from previously disclosed data in patients with CLDN18.2 expression ≥10%, ≥1+ per the LDT assay used to select patients; median follow-up for the 49 patients was 11.3 months, with 42 patients having measurable lesions at baseline; 28 achieved partial response, with 23 as confirmed response (54.8%, 23/42); median duration of response of those 23 responders was 12.7 months; 20 of 49 patients had progression of disease or death, with an estimated median progression-free survival of 14 months; median overall survival was not reached 10/24/2023

Notes

The date indicated refers to the BioWorld conference table in which the news item can be found.

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