CytoDyn Inc revealed that it has submitted to the US Food and Drug Administration (FDA) an application for Breakthrough Therapy designation (BTD) for its flagship drug leronlimab as a potential treatment for Metastatic Triple-Negative Breast Cancer (mTNBC).
The Vancouver, Washington-based late-stage biotechnology company said the application is based on the data analysis reported by the company on November 3, 2021.
The company’s Chief Medical Officer Scott Kelly shared early findings from the study with the medical and scientific communities at the Triple-Negative Breast Cancer Drug Development Digital Summit in April 2021. Dr Nitya Ray, CytoDyn’s COO and CTO, has led the BTD effort in collaboration with experts in oncology and regulatory affairs.
READ: CytoDyn reveals ‘very strong’ updated results for cancer patients receiving its flagship drug leronlimab
As previously reported, the findings represent the analysis of data from 28 pooled patients, 16 from the company’s Compassionate Use Study, 10 from the Phase 1b/2 study, and 2 from the Basket study. All subjects received ≥1 dose of leronlimab (range 1-51 doses) subcutaneously in conjunction with standard of care (SOC) systemic chemotherapy.
Of the 28 subjects, nine subjects received 350mg weekly dose and 19 subjects received 525mg or 700mg weekly dose (four subjects had dose escalation from 350mg to 525mg and were included in the higher dose cohort). The median age of the subjects was 52 years (range 33-84 years).
All subjects were diagnosed with Stage IV mTNBC. Of the 28 subjects, 17 (61%) started with visceral metastases, while six (21%) started with brain metastases, and three (11%) had bone-only metastases.
The LifeTracDx liquid biopsy algorithm developed by Creatv MicroTech Inc. was used to evaluate patient response to leronlimab. The algorithm measured change in circulating tumor cells, change in cancer-associated macrophage-like cell (CAML) number, and change in CAML size, at the blood draw at baseline and after first therapy.
Key findings from a pooled analysis of efficacy data of 28 subjects with mTNBC, including those with brain or bone metastases, who had failed ≥ 2 lines of prior systemic therapies, are as follows:
The median overall survival (mOS) for patients that received higher doses (≥ 525 mg) of leronlimab plus chemotherapy was more than 12 months, which is superior to SOC chemotherapy (6.6 months) or Sacituzumab Govitecan (SG) (11.8 months), an antibody drug conjugate that received accelerated approval by the FDA in 2020 and regular approval in 2021 for the treatment of patients with unresectable locally advanced or mTNBC who have received ≥ 2 prior systemic therapies. Previously SG received fast track and breakthrough therapy designations.
The mOS for patients that received leronlimab plus carboplatin was 12+ months, said the company. There were 13 mTNBC patients in that group.
The median progression-free survival (mPFS) for patients that received higher doses (≥ 525 mg) of leronlimab plus chemotherapy was 6.2 months, which is significantly longer compared to SOC chemotherapy (2.3 months) or SG (4.8 months).
In a statement, CytoDyn CEO Nader Pourhassan said: “In our view, these findings provide strong support for our decision to submit an application for Breakthrough Therapy designation for leronlimab as a treatment for mTNBC. Patients with this horrific disease currently have few, if any, treatment options, and we hope that leronlimab can provide a therapeutic choice for substantially improved clinically relevant endpoints, quality of life, tolerability and safety over currently available standard of care.”
“We hope to receive a response from the FDA before the end of the year. We are grateful to have already received Fast Track designation for leronlimab for this indication (mTNBC) and congratulate Dr Nitya Ray and his team for preparing the data analysis needed to file this BTD application so quickly.”
Breakthrough therapy designation is intended to expedite the development and review of drugs for serious or life-threatening conditions.
The FDA has already granted CytoDyn Fast Track designation to explore two potential indications using leronlimab to treat Human Immunodeficiency Virus (HIV) and metastatic triple-negative breast cancer (mTNBC).
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
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