Results from Ph 2 POC study of HLX43 in recurrent/metastatic cervical cancer published
By the data cutoff date of September 1, 2025, 30 patients were enrolled and randomized to receive HLX43 at 2 mg/kg (n=10), 2.5 mg/kg (n=10) and 3 mg/kg (n=10). Over 80% of the patients had a PD-L1 combined positive score ≥ 1. The median line of prior antitumor therapy was 2.0 (range, 1–4). All patients received platinum-based chemotherapy, 60% received targeted therapy, approximately 50% received immunotherapy, and the median follow-up time was 3.5 months. Among the 29 response evaluable patients, investigator-assessed ORR was 41.4% and disease control rate (DCR) was 82.8%. ORR, and DCR for the 3 mg/kg dose group was 70.0%, and 100%, respectively. The median Progression-Free Survival (PFS) has not yet been reached.
Share:
More News
“The positive outcome of our pre-IND interactions with the FDA reinforces the development pathway for MaaT034 and supports its continued advancement toward the clinic. It also represents an important step in MaaT Pharma’s expansion into immuno-oncology, highlighting the broader potential of our first in class co-cultivated microbiome donor-independent platform across
“Patients with metastatic RAS G12D non-squamous NSCLC, occurring in approximately 4% of cases, represent an underserved population, with no approved targeted treatment options. Initial clinical data evaluating zoldonrasib in combination with standard of care pembrolizumab and platinum doublet chemotherapy in patients with previously untreated metastatic RAS G12D non-squamous NSCLC showed
“At Georgiamune, we are focused on uncovering novel mechanisms that control immune-cell function and translating that biology into first-in-class medicines across autoimmune disease and oncology,” said Samir N. Khleif, M.D., Founder and Chief Executive Officer of Georgiamune. “GIM-621 is one of multiple programs to emerge from that work, alongside three
“Our team’s outstanding execution has enabled us to rapidly advance three programs into the clinic in 2026 and make significant progress in developing next-generation IO, ADC and combination therapies. Together with our partner, Kelun-Biotech, we have achieved seven IND clearances to date, and by mid-2027, we expect more than 2,000