InxMed IN10018 at ASCO 2022 demonstrates robust efficacy in patients with recurrent platinum-resistant ovarian cancer
NANJING, China, May 292022 /PRNewswire/ — InxMed Co., Ltd, a clinical-stage biotechnology company dedicated to developing innovative therapies targeting the stromal microenvironment and drug resistance for difficult-to-treat solid tumors, is pleased to announce that clinical data from an open-label phase Ib trial evaluating the efficacy and safety of IN10018, a highly potent and selective oral focal adhesion kinase (FAK) inhibitor, in combination with pegylated liposomal doxorubicin (PLD) in patients with recurrent platinum-resistant ovarian cancer (PROC), will be presented as a poster at the upcoming 2022 American Society of Clinical Oncology (ASCO) Annual Meeting of June 3, 2022 at June 7, 2022. The summary has been published on the ASCO website（Abstract #：5567）. The data showed that patients receiving a combination of IN10018 with PLD demonstrated promising antitumor activities and a manageable safety profile in PROC patients, with a high overall response rate (ORR) of 56.7%.（Poster #：445）.
This phase Ib study aims to evaluate the safety, tolerability and antitumor activities of IN10018 in combination with PLD in patients with recurrent platinum-resistant ovarian cancer. The primary endpoint of the study is objective response rate (ORR), and the key secondary endpoint includes disease control rate (DCR), duration of response (DOR), and progression-free survival (PFS).
From cut-off data of December 31, 2021, a total of 42 patients were enrolled. Antitumor response was assessed in 30 efficacy-evaluable patients who had at least one post-baseline tumor assessment by Investigator Assessment. 17 PR and 9 SD were reported and none of the patients had CR. The ORR was 56.7%, the DCR was 86.7% and the median DOR was 4.5 months (95% confidence interval [CI]: 2.7 months – NA) and still maturing. ORR and DCR were 65.0% (13/20) and 90.0% (18/20), respectively, in 20 patients with evaluable efficacy who had at least 6 months of follow-up . In all 42 patients enrolled, the median PFS was 6.2 months (95% CI: 6.2 months – NA) and maturation was still ongoing.
The safety profile of the combination is comparable to these agents alone without additive toxicities. No IN10018-related deaths were observed and only 9.5% (4/42) of patients reported SAEs which were linked to both IN10018 and PLD. The most commonly reported IN10018-related AEs were proteinuria, decreased appetite, fatigue, and gastrointestinal AEs such as nausea, diarrhea, vomiting. The majority of these drug-related AEs were CTCAE grade 1 and 2, no grade 4 or 5 drug-related AEs were reported. Proteinuria was noted as asymptomatic, reversible and manageable with appropriate dose interruption/reduction and a single event of proteinuria resulted in IN10018 dose reduction.
“We are extremely pleased with the data as it demonstrates the superior efficacy and safety of our IN10018, as well as confirming the evidence for the mechanism of the IN10018 diet. We are excited about this result and are working hard to complete this study and determine the design for further pivotal study,” said Dr. Zaiqi Wang, CEO of InxMed. FAK is a non-receptor tyrosine kinase that plays an important role in cell adhesion, migration and regulation. It exhibits positive regulation of expression in multiple tumor types.Researchers have found that inhibiting the FAK signaling pathway can effectively reverse previously failed chemotherapy and targeted therapy caused by drug resistance and improve the response and efficacy of immunotherapy for solid tumors.
InxMed has established a global clinical development program for IN10018, one of the most advanced FAK inhibitors. Clinical trials currently underway in the United States and China are designed for platinum-resistant ovarian cancer, metastatic NRAS mutant melanoma, triple-negative breast cancer, head and neck cancer, pancreatic cancer and other solid tumors that are still untreated efficient. IN10018 has received accelerated designation from the United States Food and Drug Administration (FDA) in August 2021and the groundbreaking designation from the China National Medical Products Administration (NMPA) for the treatment of patients with platinum-resistant ovarian cancer.
InxMed has exclusive worldwide development and commercial exploitation rights to IN10018 and expects to initiate a pivotal trial in the second half of the year.
For more information, please visit http://fr.inxmed.com/
InxMed is a clinical-stage biotechnology company established in late 2018. The company is dedicated to the development of innovative therapies targeting the stromal microenvironment and solid tumor resistance and metastasis, in particular the development of new drugs on anti-drug resistance. -PD-1/PD-L1. InxMed committees to build an efficient engine for clinical translational science and a proof-of-concept platform, driven by a deep understanding of disease biology and being a China biotech based company with global impact. We have built a translational medicine and clinical development team across Shanghai, beijing, Nankeen, United States, Canada and Australia. We have built a highly differentiated pipeline and established partnerships with various multinational pharmaceutical companies including Merck, Roche and Boehringer Ingelheim.