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  1. Analysis
May 3, 2022

Pipeline Moves: Pfizer terminates Phase II Braftovi, Mektovi trial, likely progress downturn in brain tumours

The Clinical Trials Arena team also review assets in postoperative pain, cardiogenic shock, and lymphoma.

By Adam Zamecnik, Urtė Fultinavičiūtė and Irena Maragkou

In this week’s edition of Pipeline Moves, we analyse the advancement prospects of Pfizer’s Braftovi (encorafenib) and Mektovi (binimetinib) in metastatic brain tumors after the company made an updated to a Phase II trial. We also take a look at Acadia Pharmaceuticals’ postoperative pain asset after it failed in its Phase II test.

In positive news, the Clinical Trials Arena team reviews Windtree Therapeutics in cardiogenic shock after the announcement of positive Phase II data, as well as Symphogen in lymphoma after it completed a Phase I trial.

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Road bump for Pfizer’s Braftovi, Mektovi

Pfizer’s Braftovi and Mektovi slumped in their Phase Transition Success Rates (PTSR) in metastatic brain tumours after the termination of a Phase II trial. The PTSR plunged by 20 points to 15% for both drugs.

The Phase II POLARIS study (NCT03911869) was terminated due to a lack of enrolment of the target population. POLARIS was anticipated to enrol 100 patients with BRAFV600-mutant melanoma with brain metastasis but was closed after accruing 13 participants. There were no safety, efficacy, or regulatory interactions involved in the trial sponsor’s decision.

ClinicalTrials.gov updated the trial’s listing on 25 April, with GlobalData appraising the asset a day later. PTSR is the probability, given as a percentage, of a drug progressing successfully from one development stage to the next. PTSR can be calculated for a drug by considering characteristics like therapy area, indication and molecule type.

The Braftovi/Mektovi combination is approved to treat patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation.

Acadia dips in postoperative pain

Acadia’s ACP-044 saw a decrease in its PTSR in postoperative pain after the asset failed to meet a Phase II trial’s primary endpoint. The PTSR was 16% and then dropped by 16 points. Acadia published trial results in press release on 18 April and GlobalData reviewed the asset on 20 April.

The Phase II study (NCT04855240) assessed the efficacy and safety of ACP-044 for the treatment of acute postoperative pain after bunionectomy, which is an orthopedic surgery. The trial had a primary endpoint comparing cumulative pain intensity scores over 24 hours between different doses of ACP-044 and placebo. The trends favoring the ACP-044 treatment group over the placebo group were not statistically significant.

Windtree surge in cardiogenic shock

Windtree’s istaroxime saw its PTSR in cardiogenic shock surge by 16 points to 57% after the announcement of positive Phase II data. Topline data was revealed in a 20 April press release, with the PTSR changing on 21 April. Together with the results, the study’s status also changed to completed.

The study sought to assess the safety and efficacy of istaroxime in patients hospitalised with acute decompensated heart failure (ADHF), persistent hypertension, and in early cardiogenic shock. 

According to the update on the 60-subject study (NCT04325035), the trial met its primary endpoint in the change from baseline in systolic blood pressure (SBP) area under the curve six hours after initiating infusion. Subjects treated with istaroxime are said to have performed significantly better as compared to the control group.

Istaroxime is a luso-inotrope, which is designed to improve both systolic and diastolic cardiac function. The company aims to share further details at the upcoming European Society of Cardiology Heart Failure meeting in May 2022.

Symphogen completes Phase I trial

Symphogen’s oncological asset Sym-021 saw a rise in its PTSR after a Phase I trial was completed. The PTSR increased by seven points to 58% in lymphoma. GlobalData evaluated the asset on 25 April after the ClinicalTrials.gov update on 22 April.  

The Phase I trial (NCT03311412) enrolled 91 participants with advanced solid tumour malignancies or lymphomas. The study evaluated the asset’s safety and tolerability as a monotherapy and in combination with Sym-022 and/or Sym-023.

Need to Know:

GlobalData’s proprietary model uses a combination of machine learning and an algorithm to calculate an individual drug’s PTSR. PTSR indicates the probability of a drug’s advancement to the next stage of clinical development. The model uses data points from the individual drugs, clinical trials, regulatory milestones, company, and financial databases.

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