Ups & downs

Good month – AbbVie

AbbVie has moved a giant step closer to completing its acquisition of Allergan, after the companies entered into a consent decree agreement with the US Federal Trade Commission regarding the deal. Under the terms of the $63-billion purchase, experimental IL-23 inhibitor brazikumab will be divested to AstraZeneca, while pancreatic enzyme products Zenpep (pancrelipase) and Viokace (pancrelipase) will be offloaded to Nestlé. The deal is now expected to close in May. Also, the European Commission cleared a label change for Maviret (glecaprevir/pibrentasvir), shortening the treatment period from 12 to eight weeks in treatment-naïve, compensated cirrhotic, chronic hepatitis C (HCV) patients with genotype 3 infection. A shorter treatment duration means that “more patients with HCV can be treated with an eight-week course of Maviret in the absence of initial tests to determine their genotype or degree of fibrosis or cirrhosis," said Janet Hammond, VP, general medicine and virology therapeutic area, AbbVie.

Middling – Pfizer

Pfizer's JAK1 inhibitor abrocitinib met efficacy endpoints in a Phase III trial assessing its potential in moderate to severe atopic dermatitis. The JADE COMPARE study showed that the percentage of patients (already on background topical therapy) achieving efficacy endpoints at Week 12 was statistically superior with both doses of abrocitinib than with placebo, and that superiority was maintained at Week 16. Going forward, Pfizer says the data, along with results from other pivotal trials, will support regulatory filings, starting with the US Food and Drug Administration later this year. On the downside, Pfizer and partner Merck KGaA have terminated the Phase III JAVELIN study testing Bavencio (avelumab) for certain patients with advanced head and neck cancer. The decision follows advice from the trial's independent data monitoring committee, which determined that adding the anti-PD-L1 antibody to chemoradiotherapy (CRT) is unlikely to significantly prolong progression-free survival in this patient population, compared to standard-of-care CRT.

Bad month – AstraZeneca

A final analysis of the Phase III CASPIAN trial showed that the addition of tremelimumab to Imfinzi (durvalumab) and chemotherapy did not significantly improve overall survival (OS) in patients with extensive-stage small-cell lung cancer. Elsewhere, AZ and MSD reported results from the Phase III GY004 trial, in which cediranib, when added to Lynparza (olaparib), failed to show a statistically significant improvement in progression-free survival (PFS) compared to chemotherapy in patients with platinum-sensitive relapsed ovarian cancer. AZ also released an update from the Phase III DANUBE trial, assessing Imfinzi (durvalumab) and Imfinzi plus tremelimumab in unresectable, Stage IV (metastatic) bladder cancer. Imfinzi monotherapy did not meet its primary endpoint of improving OS versus standard of care, for patients whose tumour cells and/or tumour-infiltrating immune cells express high levels (≥25%) of PD-L1. Imfinzi in addition to tremelimumab also missed its primary endpoint in patients regardless of PD-L1 expression.