On October 22, 2023 InxMed Co., Ltd, a clinical-stage biotechnology company dedicated on developing innovative therapies to overcome drug resistance for hard-to-treat solid tumors, reported that clinical data of Ifebemtinib (IN10018), a highly potent and selective oral inhibitor of focal adhesion kinase (FAK), in platinum-resistant recurrent ovarian cancer (PROC) and triple-negative breast cancer (TNBC) has been presented at the 2023 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress taking place October 20-24 in Madrid, Spain (Press release, InxMed, OCT 22, 2023, View Source [SID1234636221]). Both of the two studies showed that patients receiving IN10018 containing regimens demonstrated promising antitumor activities with trends toward survival benefit.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Platinum-Resistant Recurrent Ovarian Cancer（Poster #：753P）
In a single-arm, open-label, phase Ib trial, PROC patients received IN10018 in combination with pegylated liposomal doxorubicin (PLD) treatment.
The combination of IN10018 with PLD showed prolonged survival in PROC patients and manageable safety profile. As of cutoff date of April 28, 2023, a total of 61 patients were enrolled with median follow-up duration of 14.0 months. Comparing with historical data by PLD alone with an ORR (Objective Response Rate) of ~10%, median PFS (Progression-Free Survival) of 3.3 months and median OS (Overall Survival) of 12 months, the ORR of PLD in combination with IN10018 was 46.3% (95% CI：32.6-60.4), the DCR (Disease Control Rate) was 83.3% (95% CI 70.7-92.1), the median PFS was 7.56 months (95% CI: 5.5 – 9.1 months), the median OS was 20.9 months (95% CI: 14.4 months – NA) and still maturing. The safety profile of the combination is comparable to these single agents alone without additive toxicities.
Triple-Negative Breast Cancer (Poster#：398P)
This phase Ib/II study was to evaluate the safety, tolerability, and antitumor activity of IN10018 combined with PLD with/without anti-PD-1 antibody Toripalimab in previously-treated solid tumors with metastatic TNBC who had failed in 1-2 lines of systemic therapy.
As of the cutoff date of August 31, 2023, 12 patients received IN10018 + PLD (doublet) and 14 patients received IN10018 + PLD + Toripalimab (triplet). Historical data showed a median PFS was 4.3 months when PLD and low dose of cyclophosphamide is combined with anti-PD-1. In doublet group, the median PFS was 3.65 months (95% CI：1.77-7.29), and median OS was 8.26 months (95% CI, 5.59-NA). In triplet group, the median PFS was 7.43 months (95% CI：3.02-10.8), and median OS was not reached with the low boundary of 95% CI as 9.26 months. The safety profiles of both doublet group and triplet group in metastatic TNBC are tolerable and comparable to each single agent alone.
FAK signaling has been shown to be critical in pathologic fibrosis and is hyperactivated in many cancer types. FAK activation is correlated with poor survival and treatment resistance of tumors.
InxMed is developing IN10018 globally. IN10018 has received fast track designation from the U.S. Food and Drug Administration (FDA) and breakthrough designation from China National Medical Products Administration (NMPA).
A placebo-controlled, randomized, double-blind Phase II pivotal trial is ongoing to confirm the observed efficacy and safety of IN10018 in PROC. New Drug Application (NDA) is expected to be submitted in 2024.