Preliminary Results Show Significant Increase in Overall Survival Among Breast Cancer Patients Receiving Leronlimab

A decrease in cancer-associated macrophage-like cells was associated with an approximately 300% increase in mean progression-free survival.

More than 70% of patients with metastatic triple-negative breast cancer (mTNBC) who received 4 doses of leronlimab experienced significant decreases in cancer-associated macrophage-like cells (CAMLs), according to a press release from CytoDyn.

Leronlimab is a CCR5 antagonist with multiple potential therapeutic indications, according to the press release. Based on the new results and the existing FDA Fast Track designation of leronlimab for mTNBC, CytoDyn plans to seek FDA guidance on proceeding with an expedited regulatory plan for approval.

“We are very excited about these preliminary results and are eager to discuss the next regulatory steps based on this data,” said Scott Kelly, MD, chief medical officer and chairman of the board at CytoDyn, in the press release. “Based on leronlimab’s mechanism of action, we believe these results may provide tangible hope for patients suffering from mTNBC, and potentially other forms of cancer.”

The findings come from the company’s phase 1b/2 trials and compassionate use among a total of 30 patients with mTNBC. Patients in the trials were treated with leronlimab in combination with carboplatin.

According to the press release, 72% of the patients saw a decrease in CAMLs approximately 30 days after induction of leronlimab. This decrease was associated with an approximately 300% increase in mean progression-free survival and an approximately 450% increase in overall survival at 12 months.

“The fact that greater than 70% of patients saw positive changes in circulating tumor cells after a single dose of leronlimab was made even more informative by their dramatic increases in both progression-free survival and overall survival,” said Daniel Adams, director of clinical research and development at Creatv Micro Tech, Inc, in the press release. “The fact that a large group of patients taking leronlimab had an mPFS of approximately 6 months is well beyond that experienced with current treatment options available to these women, who typically have mPFS of approximately 2 months.”

High CCR5 in biopsies of tumor tissue may help to stratify patients most likely to progress on leronlimab, according to the study authors. Decreases in CAMLs and circulating tumor cells (CTCs) appear to be related to slower progression and lower mortality, and CAMLs appear to identify populations who are responding to leronlimab.

REFERENCE

CytoDyn Announces Preliminary Results from 30 mTNBC Patients Treated with Leronlimab. News release. CytoDyn. July 19, 2021. Accessed July 26, 2021. https://d1io3yog0oux5.cloudfront.net/_b274e31ddc2f9b630594ffd368c5c2c0/cytodyn/news/2021-07-19_CytoDyn_Announces_Preliminary_Results_from_30_544.pdf