ARMO BioSciences Enrolls First Patient in the CYPRESS 2 Trial Evaluating AM0010 in Non-Small Cell Lung Cancer

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ARMO BioSciences Enrolls First Patient in the CYPRESS 2 Trial Evaluating AM0010 in Non-Small Cell Lung Cancer

ARMO BioSciences, Inc. (Nasdaq:ARMO), a late-stage immuno-oncology company, today announced enrollment of its first patient in CYPRESS 2, a randomized Phase 2b trial designed to investigate pegilodecakin (AM0010) in combination with nivolumab as a second-line treatment for patients with metastatic non-small cell lung cancer (NSCLC).  The CYPRESS 2 trial will focus on NSCLC patients whose tumors express low (<49-1%) or negative (<1%) levels of PD-L1.

“We are pleased to have dosed the first patient in our CYPRESS development program, which will guide our registrational strategy for pegilodecakin in NSCLC,” said Joseph Leveque, MD, Chief Medical Officer of ARMO Biosciences.  “In our Phase 1 b trial, pegilodecakin showed very encouraging disease control (DCR), overall response (ORR), progression-free survival (PFS) and overall survival (OS) when combined with pembrolizumab or nivolumab, regardless of the PD-L1 expression, tumor mutational burden (TMB) or disseminated disease in NSCLC patients.   We expect that the CYPRESS studies could provide confirmatory translational data to our Phase 1b experience and will allow us to define targeted registrational studies with pegilodecakin in these tough to treat patient populations, which could potentially commence as early as 2019.”

Cypress 2 is a randomized study seeking to enroll a total of 100 NSCLC patients that will be randomized on a one-to-one basis between the intervention arm which will receive pegilodecakin in combination with nivolumab (Opdivo®), and the control arm which will receive only nivolumab.  To be enrolled in the trial, patients must have a confirmed diagnosis of metastatic NSCLC, must have received only one prior course of therapy which does not contain a checkpoint inhibitor and must be confirmed as having low (<49%) or negative PD-L1 (<1%) expression.  The primary endpoint on the study is ORR, and secondary endpoints include PFS and OS among others.  In addition to PD-L1 expression, key biomarkers such as TMB and gamma-interferon expression profile (GEP) will be evaluated for each patient.  The Company is also in the process of enrolling patients in the CYPRESS 1 study, which will evaluate pegilodecakin in combination with pembrolizumab (Keytruda®) in first-line NSCLC patients whose tumors have high PD-L1 expression (>50%).

“With the first patient dosed in our CYPRESS development program, we have achieved another key milestone for the company in 2018,” said Peter Van Vlasselaer, PhD Chief Executive Officer of ARMO Biosciences.  “With more than 10 sites already active and screening patients, and many more coming on-line in the coming weeks, we are ahead of schedule and remain on track to deliver on our plans for the CYPRESS studies to provide robust randomized data on NSCLC patients in the second half of 2018.  This data will be critical in guiding our design and accelerating the commencement of registrational studies in NSCLC.”

Given the unblinded nature of both CYPRESS studies, the company plans to provide periodic updates on progress in each over the course of 2018, and expects to complete enrollment of both CYPRESS 1 and CYPRESS 2 in the first half of 2019.

Press Release