The FDA Approves AstraZeneca Checkpoint Inhibitor Imfinzi® for a Lung Cancer. A Probable Partnership Agreement Between Arbutus and Roivant

The Food and Drug Administration (FDA) approved AstraZeneca (AZN) Checkpoint inhibitor drug Imfinzi® (durvalumab) for patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (CRT).

Explaining the importance of this approval, Scott J. Antonia, M.D., Ph.D., Chair of the Thoracic Oncology Department at the H. Lee Moffitt Cancer Center and Research Institute in Tampa, Florida and investigator in the PACIFIC trial, said, “Until now, the treatment guidelines recommend that patients with unresectable Stage III lung cancer undergo a period of active surveillance following chemoradiation therapy until disease progression. Given that up to 89% of patients will progress to metastatic disease, it is important that there is now a new option that can give patients more time without disease progression. The PACIFIC trial data supporting today’s approval of IMFINZI will change how we treat these patients.”

The approval of Imfinzi is based on the positive progression-free survival (PFS) data from the Phase III PACIFIC trial in which Imfinzi demonstrated an improvement in median PFS of 11.2 months compared to placebo. This improvement represents a 48% reduction in relative risk of progression or death vs placebo in all patients, regardless of PD-L1 status.

Important to note that the PACIFIC trial is still ongoing to evaluate overall survival (OS) in unresectable Stage III NSCLC.

Detailed interim results of the PACIFIC trial were published online in the New England Journal of Medicine.

Prohost Observations

The approval of AstraZeneca product adds to the cancer market another immune checkpoint inhibitor targeting PD-L1. More important is that durvalumab has demonstrated its ability to extend the progression-free survival of unresectable Stage III lung cancer people following chemoradiation therapy until disease progression. These people had no treatment that can help extend their PFS to them in this setting.

The approval of Imfinzi® (durvalumab) brings good news to the patients, the oncologists, and AstraZeneca.

Imfinzi® (durvalumab) is a monoclonal antibody that blocks the interaction of programmed cell death ligand 1 (PD-L1) with the PD-1 and CD80 (B7.1) molecules.


Arbutus and Roivant Probable Agreement  

Arbutus Biopharma (ABUS) and Roivant entered into an Exclusivity Agreement providing for a period that expires on March 15, 2018. Pursuant to the Exclusivity Agreement, during this period, Arbutus and Roivant agree to negotiate on an exclusive basis the terms and conditions of a proposal to jointly develop Arbutus’ nucleic acid delivery platform based on its Lipid Nanoparticle (LNP) technology and GalNAc technology (collectively, Delivery Technologies) through a new company that would jointly own, manage, and develop the Delivery Technologies. There are no assurances that Arbutus and Roivant will reach an agreement regarding any such transaction or that any such transaction will be consummated.

Prohost Observations

We are waiting to see whether these two firms would reach an agreement. Yet, regardless of the outcome of the negotiations, Roivant interest in Arbutus delivery technologies highlights Arbutus sciences and capability to deliver.

Arbutus, we remind, is developing capsid inhibitors as oral therapeutics to hinder the ability of hepatitis B virus to replicate. The firm’s AB-423: is the first-generation capsid inhibitor in Arbutus pipeline. This product was evaluated in a Phase I Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) trial in healthy volunteers.

Results demonstrate that the drug was generally well-tolerated with no serious adverse events following single doses up to 800mg and multiple doses up to 400mg twice daily. AB-423 has demonstrated favorable safety and pharmacokinetics (PK) given in single and multiple doses administered to healthy volunteers. This safety supported further evaluation in multiple-dose administration of the product in patients with chronic hepatitis B virus (HBV).

Arbutus has considered inclusion in a combination study with its other proprietary HBV assets, nucleot(s)ide analog, and interferon therapies.

The firm’s drug AB-506 referred to by the firm as a next-generation capsid inhibitor is currently undergoing Investigational New Drug (IND)-enabling studies. AB-506 demonstrated favorable PK and potency profiles. Pending successful IND-enabling studies, this product candidate could be the subject of an Investigation New Drug (or equivalent) filing.

We are waiting to hear from the firm about the outcome of the negotiation with Roivant. 

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