On May 29, 2020 Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) reported the presentation of data from the endometrial cancer cohort of Part 2 of its ongoing Phase 1b/2 clinical trial of rebastinib, the Company’s investigational orally administered, potent and selective inhibitor of the TIE-2 kinase, in combination with paclitaxel (Press release, Deciphera Pharmaceuticals, MAY 29, 2020, View Source [SID1234558700]). The presentation, titled "An open-label, multicenter, phase 1b/2 study of rebastinib in combination with paclitaxel in a dose expansion cohort to assess safety and preliminary efficacy in patients with advanced or metastatic endometrial cancer" (abstract 6085; poster 256), will be featured during a poster session at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Scientific Program.

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"We are very encouraged by the preliminary data from the endometrial cancer cohort," said Matthew L. Sherman, M.D., Executive Vice President and Chief Medical Officer of Deciphera. "Of the 18 patients included in the modified intent-to-treat population, there were seven partial responses observed, four of which were confirmed, and six patients had stable disease, for an objective response rate of 39% and a clinical benefit rate of 72% at eight weeks. These findings continue to support the potential of TIE-2 inhibition with rebastinib in combination with paclitaxel, including in patients with prior exposure to paclitaxel."

The Phase 1b/2 study of rebastinib in combination with paclitaxel is a two-part, open-label, multicenter study assessing the safety, tolerability, anti-tumor activity and pharmacokinetics of rebastinib in patients with advanced or metastatic solid tumors. Data previously presented from Part 1 of the study demonstrated encouraging preliminary anti-tumor activity, with objective responses seen across a heavily pre-treated patient population, including patients with prior exposure to paclitaxel. As previously announced, both the endometrial and ovarian cancer cohorts in Part 2 of the study advanced into the second stage of the Simon two-stage design based on demonstrating at least five responses in each cohort.

As of a February 22, 2020 data cutoff date, a total of 21 patients initiated treatment with rebastinib in the Part 2 cohort of endometrial cancer patients. Median duration of treatment was 3.7 months. Sixteen patients were treated at a starting dose of 100 mg of rebastinib twice daily (BID) + weekly paclitaxel 80 mg/m2 and five patients at a starting dose of 50 mg of rebastinib BID + weekly paclitaxel 80 mg/m2. Three of the 21 patients withdrew consent early, resulting in 18 patients in the modified intent-to-treat (mITT) population.

Preliminary results included:

Encouraging anti-tumor activity of rebastinib in combination with paclitaxel in the heavily pre-treated endometrial cancer patient population.
Of the 21 patients treated with the combination, all received one or more prior lines of the combination of paclitaxel/carboplatin, and 20 of 21 received two or more prior anti-cancer regimens.
Of the 18 patients included in the mITT population, seven partial responses were observed (four confirmed) and six patients had stable disease, for an objective response rate of 39% and a clinical benefit rate of 72% at eight weeks.
Treatment with rebastinib 50 mg BID in combination with paclitaxel was well-tolerated, with treatment-emergent adverse events consistent with findings from Part 1 of the study and consistent with first-in-human studies of rebastinib, or known to be associated with treatment with paclitaxel.
Enrollment in Stage 2 of the endometrial cohort at the rebastinib 50 mg BID dose is nearly complete and further efficacy and safety evaluation is ongoing.

A copy of the poster presentation is available at View Source

About Rebastinib

Rebastinib is an investigational, orally administered, potent and selective inhibitor of the TIE2 kinase, the receptor for angiopoietins, an important family of vascular growth factors in the tumor microenvironment that also activate pro-tumoral TIE2 expressing macrophages. In a Phase 1 clinical study, biomarker data have demonstrated rebastinib-induced increases in the TIE2 ligand angiopoietin 2, providing evidence of TIE2 inhibition. Rebastinib is currently being evaluated in a Phase 1b/2 clinical study in combination with paclitaxel (NCT03601897) and in a Phase 1b/2 clinical study in combination with carboplatin (NCT03717415).