Ivonescimab

Ivonescimab showed significant improvement in progression-free survival vs. pembrolizumab for PD-L1-positive advanced NSCLC patients, with a median PFS of 11.14 months vs. 5.82 months, according to the HARMONi-2 study presented at IASLC 2024 WCLC.

Akeso's PD-1/VEGF bispecific antibody ivonescimab showed significant results in a Phase II study for perioperative treatment of resectable NSCLC, with high rates of pCR and MPR. Ivonescimab + chemotherapy had higher pCR and MPR rates compared to monotherapy. Safety profile was manageable, with no TRAEs affecting surgery. Ivonescimab is undergoing multiple Phase III studies and is engaged in over 25 clinical trials across 17 indications.

Ivonescimab showed a median PFS of 11.14 months vs. 5.82 months with pembrolizumab, offering a 49% reduction in progression risk. Benefits were consistent across various subgroups, with comparable safety profiles. Dr. Caicun Zhou highlights ivonescimab's potential as a new standard of care for PD-L1-positive advanced NSCLC.

Summit Therapeutics' experimental drug, ivonescimab, reduced lung cancer progression risk by 49% compared to Merck's Keytruda in a Phase 3 trial, showing a 5.3-month longer median progression-free survival. The study, conducted in China, did not compare ivonescimab to Keytruda plus chemotherapy, which is standard for many cases. Summit plans further global studies to address these limitations.

Ivonescimab showed improved mPFS (11.15 months vs. 5.82 months) and reduced PFS HR (0.51, P<0.0001) vs. pembrolizumab in 1L PD-L1+ advanced NSCLC. ORR and DCR were also higher with ivonescimab (50.0% vs. 38.5%, 89.9% vs. 70.5%). Ivonescimab demonstrated significant PFS benefits across PD-L1 expression, histology, and refractory subgroups, with an acceptable safety profile. HARMONi-7, a phase III trial, is planned for 1L PD-L1 high advanced NSCLC in early 2025.

Ivonescimab monotherapy reduced disease progression or death risk by 49% vs. pembrolizumab in PD-L1+ advanced NSCLC. Median PFS was 11.14 months for ivonescimab vs. 5.82 months for pembrolizumab. HARMONi-7 Phase III trial initiation planned for 2025.

Summit Therapeutics announces HARMONi-2 Phase III trial results for ivonescimab in advanced NSCLC, showing significant PFS improvement over pembrolizumab. Ivonescimab demonstrated a median PFS of 11.14 months vs. 5.82 months for pembrolizumab, with comparable safety profiles. HARMONi-7 trial initiation planned for early 2025.

Summit Therapeutics announces Phase III HARMONi-2 trial results showing ivonescimab's superior PFS (11.14 months vs. 5.82 months for pembrolizumab) in advanced NSCLC, with comparable safety profiles. The company plans to initiate HARMONi-7 in early 2025, a multi-regional Phase III trial for first-line PD-L1 high metastatic NSCLC.

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.

Akeso, Inc. reported significant advancements in cancer immunotherapy, with ivonescimab and cadonilimab leading as bispecific antibodies. Ivonescimab, approved for EGFRm NSCLC, shows promise in multiple Phase III trials. Cadonilimab, targeting PD-1/CTLA-4, is advancing in trials for various cancers. Akeso's innovative therapies, including ADCs and bispecific antibodies, are progressing, with strong commercial growth and a robust clinical pipeline.