Study to evaluate DF9001 plus pembrolizumab in solid tumors, including RCC

Dragonfly Therapeutics recently announced a new collaboration with Merck to explore the combination of their therapies, DF9001 and pembrolizumab (Keytruda), respectively, in the treatment of adult patients with advanced solid tumors expressing epidermal growth factor receptor (EGFR), including renal cell carcinoma (RCC).¹

Primary completion of the study is expected in August 2025.

DF9001 is an EGFR immune engager that is currently being investigated as a monotherapy in patients with RCC, head and neck squamous cell carcinoma (HNSCC), and non-small cell lung cancer (NSCLC). The recent clinical trial collaboration will allow for expansion of the phase 1 study to explore the safety, tolerability, and clinical activity of DF9001 in combination with pembrolizumab as an investigational second-line treatment for patients with RCC and HNSCC.

"We are pleased to enter into this agreement with Merck for our ongoing, investigational phase 1 trial of DF9001,” said Bill Haney, co-founder and CEO of Dragonfly Therapeutics, in the news release.¹ “In preclinical models, DF9001 engages multiple immune effector cells to drive anti-tumor activity and induces PD-L1 expression in tumor cells, sensitizing cold tumors to checkpoint inhibitors. We are hopeful that DF9001 in combination with KEYTRUDA will drive potent anti-tumor activity in a broad range of indications and are excited to further accelerate progress in the clinic to benefit patients in need."

According to the news release, the first-in-human study plans to begin dosing patients with DF9001 in combination with pembrolizumab in Q4 of 2024. Overall, the trial plans to enroll 242 adult patients with EGFR-positive advanced solid tumors, with each monotherapy and expansion combination cohort enrolling approximately 20-40 patients.²

Clinical trial sites for the monotherapy cohorts of the study are currently open across the United States, with additional sites expected to open across North American and Europe later this year.

General inclusion criteria for the trial includes participation in the use of contraception during the study (and for 150 days after the last dose for female patients of child-bearing potential and after 30 days for male patients) in addition to adequate hematological function, adequate hepatic function, and adequate renal function. Further, participants must have an ECOG score of 0 or 1 at study entry and an estimated life expectancy of at least 3 months. Additional inclusion criteria for the specific expansion cohort must also be met.²

The primary end points for the study are the number, severity, and duration of treatment-related adverse events (TRAEs); the number of patients with adverse events and TRAEs; dose-limiting toxicities; and the overall response rate. Secondary end points for the study are serum concentrations of DF9001, best overall response, duration of response, and progression-free survival.

Primary completion of the study is expected in August 2025, with final completion anticipated for 2027.

References

1. Dragonfly Therapeutics, Inc. announces clinical collaboration to evaluate DF9001, an EGFR targeting TriNKET, in combination with KEYTRUDA (pembrolizumab) in patients with solid tumors. News release. Dragonfly Therapeutics, Inc. May 21, 2024. Accessed May 22, 2024. https://www.dragonflytx.com/post/dragonfly-announces-clinical-collaboration-to-evaluate-df9001-in-combination-with-keytruda-in-patie

2. Study of DF9001 in patients with advanced solid tumors. ClinicalTrials.gov. Last updated May 16, 2024. Accessed May 22, 2024. https://clinicaltrials.gov/study/NCT05597839