Forteca (prolgolimab)

The Nuru+Prolgo fixed-dose combination demonstrated significantly superior efficacy versus aPD-1 monotherapy in first-line un/mM, with a manageable safety profile.

A comprehensive ensemble radiomics approach was applied to pretreatment CT scans to prognosticate overall survival (OS) and predict progression-free survival (PFS) in a cohort of 220 consecutive patients with inoperable NSCLC treated with first-line ICIs (pembrolizumab or atezolizumab, nivolumab or prolgolimab) as monotherapy or in combination. Predictive performance was lower for 6-month (AUC = 0.719) and 12-month PFS (AUC = 0.739) endpoints. Our radiomics pipeline improved selection of NSCLC patients for immunotherapy and could spare non-responders unnecessary toxicity while enhancing cost-effectiveness.

Among patients with advanced NSCLC the addition of prolgolimab to pemetrexed and a platinum-based drug increased OS and PFS, with no new safety concerns. This benefit was retained in patients with PD-L1 negative tumors. (ClinicalTrials.gov, NCT03912389).

P2, N=30, Recruiting, Blokhin's Russian Cancer Research Center

At relapse, 3 patients were administered brentuximab vedotin monotherapy at 1.8 mg/kg every 21 days (median 10; range 8-14 doses), but had disease progression...Chemo mobilization with etoposide performed, the median number of collected CD34+ cells was 5.6 x10^6/kg... Previously published retrospective results indicate that immunotherapy with PD-1 inhibitors (nivolumab, pembrolizumab), which has been used in the treatment of r/refractory HL in the Russian Federation since 2017, is highly effective in combination with chemotherapy (approximately 70%) and safe in terms of toxicity. The most common grade 3-4 adverse events were increased lipase levels (up to 5% of cases), neutropenia (3%), diarrhea (1%), rash (1%), autoimmune complications (<1%). Our results demonstrate that the combination of the new PD-1 inhibitor prolgolimab and DHAP can be synergistic, highly effective, and extremely safe, serving as a potentialbridge to consolidation therapy.

58 patients (pts) with metastatic or recurrent/persistent CC with measurable disease received prolgolimab (3 mg/kg) Q3W together with paclitaxel, platinum drug (cis- or carboplatin) and bevacizumab for 6 cycles and then therapy with prolgolimab and bevacizumab until disease progression or toxicity. Prolgolimab in combination with chemotherapy and bevacizumab demonstrated promising efficacy, known and acceptable safety profile in pts with advanced CC. Phase III placebo-controlled trial evaluating prolgolimab with chemotherapy and bevacizumab (NCT03912415) as first-line therapy option in subjects with CC is ongoing. Clinical trial information: NCT03912402.

P3, N=114, Active, not recruiting, Biocad

P2/3, N=218, Active, not recruiting, Biocad | Trial completion date: Oct 2019 --> Aug 2021 | Trial primary completion date: Oct 2019 --> Aug 2020

In this unanchored MAIC, prolgolimab showed comparable efficacy with other PD-1 inhibitors in monotherapy (nivolumab, pembrolizumab) and in combination with CTLA-4 inhibitor (nivolumab + ipilimumab) based on OS and PFS after 1 year from therapy initiation in patients with metastatic or unresectable melanoma. This analysis may be relevant for clinical decision-making, thus improving the treatment of patients with advanced melanoma.

P2, N=126, Active, not recruiting, Biocad | Trial completion date: Dec 2019 --> Jan 2021

P2, N=112, Recruiting, Biocad | Not yet recruiting --> Recruiting | Trial completion date: Sep 2022 --> Nov 2021

P3, N=316, Ongoing, JSC BIOCAD