Summit Therapeutics and Innovent Biologics presented updated clinical data on their investigational therapies, ivonescimab and IBI363, respectively, at the European Society for Medical Oncology (ESMO) Annual Meeting 2024 in Barcelona, Spain. These data, along with other studies presented, highlight potential advancements in the treatment of various advanced solid tumors.
Ivonescimab Shows Promise in Multiple Solid Tumors
Summit Therapeutics announced updated data on ivonescimab, a novel bispecific antibody, from Phase II studies conducted by Akeso Inc. The presentations featured data in advanced triple-negative breast cancer (TNBC), recurrent/metastatic head and neck squamous cell carcinoma (HNSCC), and metastatic microsatellite-stable (MSS) colorectal cancer (CRC).
One oral presentation by Dr. Yanhong Deng from Sun Yat-Sen University, focused on the AK112-206 study (NCT05382442), a Phase II randomized trial of ivonescimab plus Folfoxiri (chemotherapy) with or without ligufalimab (anti-CD47 monoclonal antibody) as first-line treatment for metastatic MSS CRC. As of February 29, 2024, 22 patients received ivonescimab plus Folfoxiri (Group A), and 18 patients received ivonescimab plus ligufalimab plus Folfoxiri (Group B). All patients in both groups experienced a reduction in tumor burden compared to baseline. The overall response rate was 84.6%, and the disease control rate was 100%. The median progression-free survival was not reached in either group at the time of analysis. The most common treatment-related adverse events were anemia, proteinuria, white blood cell count decreases, and neutrophil count decreases.
Another oral presentation by Dr. Xiaojia Wang from Zhejiang Cancer Hospital, highlighted data from the AK117-203 study (NCT05227664), a Phase II study assessing ivonescimab plus chemotherapy (paclitaxel or nab-paclitaxel) in locally advanced or metastatic TNBC. As of May 31, 2024, 30 patients received ivonescimab plus chemotherapy with a median follow-up of 10.2 months. Sixty percent of patients had previously received taxane-based chemotherapy in the neoadjuvant or adjuvant setting.
IBI363 Demonstrates Anti-Tumor Activity in Advanced Colorectal Cancer
Innovent Biologics presented clinical data on IBI363, a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, combined with bevacizumab in advanced colorectal cancer. The Phase 1 study evaluated the safety, tolerability, and preliminary efficacy of the combination in subjects with advanced colorectal cancer. A total of 35 subjects received treatment at three different dose levels. The most common treatment-related adverse events were arthralgia, thyroid disorders, and rash. The total incidence of TRAEs ≥ grade 3 was 22.9%. Immune-related adverse events ≥ grade 3 occurred in 5.7% of subjects. The ORR was 21.9% (confirmed ORR was 15.6%), and DCR was 65.6%. The median DoR was 8.1 months, and the median PFS was 4.1 months. These results suggest that IBI363 combined with bevacizumab holds significant promise for colorectal cancer and deserves further exploration.
Other Notable Findings at WCLC and ESMO
Updated results from the Phase 3 MARIPOSA study showed a significant improvement in overall survival with amivantamab plus lazertinib over osimertinib in patients with previously untreated, EGFR-mutant, advanced NSCLC (NCT04487080). At a median follow-up of 31.1 months, the median OS was not reached with the combination and was 37.3 months with osimertinib (HR, 0.77; 95% CI, 0.61-0.96; P =.019).
In the realm of small cell lung cancer (SCLC), sacituzumab govitecan and ifinatamab deruxtecan (I-DXd) demonstrated activity in extensive-stage SCLC (ES-SCLC). The TROPiCS-03 trial (NCT03964727) showed an ORR of 41.9% with sacituzumab govitecan in patients with ES-SCLC who had received one prior line of platinum-based chemotherapy and anti-PD-(L)1 therapy. The IDeate-Lung01 trial (NCT05280470) demonstrated clinically meaningful efficacy with I-DXd in heavily pretreated patients with ES-SCLC, with the 12 mg/kg dose demonstrating approximately twice the confirmed ORR of the 8 mg/kg dose.
These studies collectively suggest potential new treatment options and strategies for patients with advanced solid tumors, addressing unmet needs in various cancer types.
