BioPharma

Merck to acquire ArQule, maker of blood cancer drug, for $2.7B

ArQule's lead product candidate is a BTK inhibitor, ARQ-531, designed for heavily pretreated patients with leukemias and lymphomas, particularly those whose disease has become resistant to marketed BTK therapies. Phase I data on the drug were also presented Monday.

Just in time for a major annual conference focused on blood cancers and blood disorders, Merck & Co. is acquiring a company developing a drug belonging to a growing class used to treat leukemia and lymphoma that affects B cells.

The Kenilworth, New Jersey-based drugmaker said Monday it would acquire Burlington, Massachusetts-based ArQule for $2.7 billion. The company’s lead asset is ARQ-531, a BTK inhibitor in a Phase II dose-expansion study for B-cell malignancies.

Shares of ArQule were up 103% on the Nasdaq following the news.

ARQ-531 is designed to target both wild-type BTK as well as the C481S mutant form of the kinase, the latter of which is associated with resistance to other BTK inhibitors. Data for the drug in chronic lymphocytic leukemia from a Phase I study are being presented Monday at the American Society of Hematology’s annual meeting in Orlando, Florida.

The data showed eight of nine patients with heavily pretreated CLL achieving partial responses, seven of whom harbored the C481S mutation. In addition, three of six patients with Richter’s transformation responded to therapy, along with one each who had follicular lymphoma and diffuse large B-cell lymphoma. Richter’s transformation is a transformation of CLL to DLBCL, which itself is a rapidly growing histology of B-cell non-Hodgkin’s lymphoma. In terms of how long patients’ responses last, all five of the CLL patients who were evaluable for durability remained on the drug after nine cycles of therapy, while two of the three evaluable Richter’s patients left the study after becoming eligible for CAR-T cell therapy.

Currently marketed BTK inhibitors include AbbVie and Johnson & Johnson’s Imbruvica (ibrutinib), AstraZeneca’s Calquence (acalabrutinib) and BeiGene’s Brukinsa (zanubrutinib). But a more direct potential competitor to ArQule’s drug could be LOXO-305, developed by Eli Lilly & Co.’s Loxo Oncology subsidiary, also for patients who have become resistant to or are ineligible for therapy with marketed BTK inhibitors, including due to C481 mutations. Loxo presented Phase I/II dose-escalation data at ASH on the drug Sunday, showing responses among resistant patients.

Photo: maxsattana, Getty Images

Shares0
Shares0