NewLink Genetics Presents Phase 2 Results for NLG207 in Ovarian Cancer at AACR 2019

NewLink Genetics (NASDAQ:NLNK) has announced results from its Phase 2 study of NLG207, a nanoparticle of the topoisomerase 1 inhibitor done in connection with the GOG Foundation in patients with refractory ovarian cancer.

As quoted in the press release:

“We are encouraged by the responses observed in this Phase 2 trial of NLG207 in combination with weekly paclitaxel for patients with recurrent ovarian, fallopian tube or primary peritoneal cancer, with good results seen in the cohort of platinum resistant and refractory patients,” said Linda R. Duska, MD, Professor of Obstetrics and Gynecology at the University of Virginia School of Medicine.  “Equally encouraging is how well tolerated this regimen was in women who have already had multiple lines of therapy.  The results from this trial demonstrate the potential for NLG207 as a component of a treatment regimen for women with recurrent ovarian cancer, especially for those resistant to platinum therapy, an area of unmet need.”

Background:

NLG207 (formerly CRLX101), a nanoparticle-drug conjugate (NDC) composed of a cyclodextrin-based polymer backbone linked to camptothecin, a topoisomerase 1 inhibitor, was previously observed to have single agent activity in both preclinical¹ and clinical studies.² A previous Phase 2 trial evaluating NLG207 administered as monotherapy enrolled 29 patients with ovarian, fallopian tube, or primary peritoneal cancer, 22 of which were classified as platinum resistant.  Of these 22 patients, 19 were evaluable for efficacy with follow-ups using computerized tomography (CT) scans performed every two cycles.  Of these 19 evaluable patients, 17 (74%) demonstrated a net tumor reduction and three (16%) achieved durable partial responses per RECIST.²

In the study reported on today, NLG207 was administered in combination with paclitaxel to patients with recurrent ovarian, fallopian tube, or peritoneal cancer in a Phase 1b/2, single-arm, open label expansion study.  Thirty patients were enrolled, and all received at least one cycle of treatment: 3 patients received the lower lead-in Phase 1b dosing schedule of 12 mg/m² i.v. (every two weeks) plus weekly paclitaxel 80 mg/m² i.v.  (three weeks on, one week off) and 27 patients received the recommended Phase II dose NLG207 15 mg/m² i.v. (every two weeks) plus weekly paclitaxel 80 mg/m² i.v.  (three weeks on, one week off).  The primary objective of the study was overall response rate (ORR = complete response [CR] + partial response [PR]) per RECIST 1.1.  Secondary objectives included evaluation of progression-free survival (PFS), PFS at 6 months (PFS6), and duration of response (DOR) in patients with recurrent platinum resistant cancer, and safety.

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