Dr Goel on the Preliminary Efficacy of Tinengotinib Monotherapy in Advanced Solid Tumors

Sanjay Goel, MD, MS, director of Phase I/Investigational Therapeutics, medical oncologist, professor of medicine, Division of Medical Oncology, Section of Solid Tumor, Rutgers Robert Wood Johnson Medical School, discusses the preliminary efficacy of tinengotinib (TT-00420)monotherapy in advanced solid tumors according to data from a phase 1b/2 trial (NCT04742959).

The phase 1b/2 trial was conducted to evaluate the safety, pharmacokinetics, and efficacy of the spectrum-selective multi-kinase inhibitor tinengotinib as a monotherapy in patients with advanced or metastatic solid tumors with no available standard treatment options. Patients enrolled in the study were assigned to 1 of 3 arms. In arm A, tinengotinib was administered orally at 12 mg once daily. In arm B, tinengotinib was administered at 8 mg, 10 mg, or 12 mg once a day alongside 100 mg of nab-paclitaxel (Abraxane) to patients with HER2-negative breast cancer. Arm C was the pharmacokinetic run-in, and involved administering tinengotinib at either 5 mg, 8 mg, 10 mg, or 12 mg once a day, or 4 mg or 6 mg twice a day to all-comers.

As of April 3, 2023, 177 patients were enrolled and treated on the study. Of the 124 efficacy evaluable patients in the monotherapy arms, the overall response rate (ORR) was 14.5% and was composed entirely of partial responses (PRs), Goel reports. The disease control rate (DCR) was 64.5%. Additionally, 25% of patients experienced clinical benefit with single-agent tinengotinib, which was defined as a complete response (CR), PR, or stable disease (SD) lasting more than 6 months, Goel states. Responses were observed across a wide range of tumor types, including cholangiocarcinoma, prostate cancer, hormone receptor (HR)–positive/HER2-negative breast cancer, and triple-negative breast cancer, he notes. Best ORR in patients with cholangiocarcinoma (n = 17) was 17.6%. Notably, this rate was 40% in those who expressed FGFRalterations. Best ORRs in the remaining 3 tumor types were 50% (n = 5/10), 33.3% (n = 2/6) and 37.5% (n = 3/8), respectively.

Clinical benefit with oral tinengotinib was also seen in patients with ovarian, squamous oropharynx, fallopian tube, urothelial, cervical, bladder, endometrial, leiomyosarcoma, melanoma, colon, duodenum, and lung cancer, Goel concludes.

Dr Goel reports receiving honoraria from Amgen and Merck; he has stock and other ownership interests with Johnson and Johnson, Merck, and Moderna Therapeutics; he received institutional research funding from BeiGene, Deciphera, Dragonfly Therapeutics, EMD Serono, PharmaMar, Takeda, and TLC PharmaChem; he has a patent with co-inventor, John Mariadason, Ph.D, entitled "Method Of Determining The Sensitivity Of Cancer Cells To EGFR Inhibitors Including Cetuximab, Panitumumab And Erlotinib.", Patent No. 20090258364.