Innate Pharma Explodes on Leukemia Drug Submission in Europe

Shares of French biotech company Innate Pharma SA were on the rise on Thursday in premarket trading. The stock gained 23% after Wall Street learned that the European Medicines Agency had accepted the company’s application for leukemia treatment Lumoxiti.

A late-stage clinical trial presented at ASH 2019, revealed that 36% of patients with relapsed or refractory hairy cell leukemia reported remission for at least 180 days.

The objective response rate (ORR) was at 75 percent. Eighty-one percent of patients with CR experienced eradication of minimal residual disease as reflected by MRD-negative status. In addition, there was a 61 percent probability that patients who achieved a CR would maintain it after five years.

It was last September that the Food and Drug Administration approved Lumoxiti.

The drugmaker said that AstraZeneca is the marketing authorization applicant for the EMA filing; AZ also holds the biologics license application in the U.S.

“If approved by the EMA, Lumoxiti will be the first treatment available in Europe for relapsed or refractory hairy cell leukemia patients in more than twenty years, potentially changing the standard of care for these patients,” commented Pierre Dodion, MD, Executive Vice President and Chief Medical Officer of Innate Pharma.

“We are dedicated in addressing the unmet need in this rare form of cancer that can result in serious and life-threatening conditions, and as such, are hopeful we can bring this important medicine to patients in Europe as soon as possible.”

Disclaimer: We have no position in INNATE PHARMA S/S ADR (NASDAQ: IPHA) and have not been compensated for this article.