To the CEO, Board of Directors, and clinical and medical staff of CytoDyn:
As a registered nurse I am excited whenever I see new cancer treatments being developed, and I congratulate you on completing the interim analysis for your mTNBC trial with leronlimab. However, I am concerned about your recent press release from this trial. The press release is misleading regarding the benefits of the drug in the trial as well as the survival rates for mTNBC. This is causing confusion and distress among some patients and family members.
Many cancer patients are very familiar with clinical trials. They have searched for them in clinical trial databases, they have experienced them firsthand as a patient, and they have spent a great deal of time reading research studies about drugs that might help them. It is heartbreaking to see how much hope and trust they put in medical research every day. That is why it is so important that trial results be reported in a way that is both accurate and easy to understand.
Your press release announces preliminary results from 30 subjects comprised of patients in both a compassionate use study and a phase 1b/2 trial. There are only one set of results given, but the two trials have different patient populations, with different survival rates. According to ClinicalTrials.gov the compassionate use study accepts only mTNBC patients whose cancer progressed after having “been treated with >/= 3 previous chemotherapy drugs”, while the phase 1b/2 study accepts only mTNBC patients who are “untreated or naïve to chemotherapy.” Previous studies have shown two different survival rates for these different patient populations, which can differ by up to 6 months. Reporting on results combining or comparing patients from both patient populations is inaccurate and misleading.
The statement by Daniel Adams, Director of Clinical Reasearch & Development at Creatv MicroTech, Inc. is particularly distressing. He says that these women “typically have an mPFS of approximately 2 months”, and “the typical mOS in this population is only 6 to 7 months.” Imagine reading this as a chemotherapy naïve patient who has already been told by her oncologist that typical patients like her have a survival rate of 12 months or more! Adding to the confusion, you have only talked about mean survival rates in your press release, while all previous clinical trials have also reported median survival rates, to eliminate skewed results due to outliers.
I hope you will consider rescinding or amending your press release for clarity.
I wish you the best of luck as you continue your clinical trial of leronlimab for mTNBC!
Sincerely,
PB, RN
