Expert Interview
Discussing the PICCOLO study data on ImmunoGen's Elahere in recurrent platinum-sensitive ovarian cancer
Ticker(s): IMGNInstitution: Inova Health
- Medical Gynecologic Oncologist at Inova Health; fellowship trained at the National Cancer Institute.
- Previously Oncologist at the Office of Oncologic Diseases at the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research, where she served as the integrative oncology liaison for the division.
- Manages 60 patients with platinum-sensitive ovarian cancer.
- Active in clinical trial research relating to ovarian cancer.
Could you please describe your background, practice and give us an estimate how many patients you treat per year and how many patients you see per month?
Zooming in into the patients' characteristics - could you give us the breakdown of patients that are platinum sensitive and platinum resistant? Could you please guide us through the current treatment algorithm?
What percentages of your patients are Folate Receptor alpha positive? What percent of the FRalpha positive population is a candidate for ELAHERE treatment according to expression level? Do you have patients on ELAHERE since its approval? What has been your experience regarding durability of the treatment?
Is the testing for Folate Receptor alpha something that can be perceived as a hurdle for adoption beyond academic centers? Do you see reported ocular tox as a barrier to adoption in community settings?
Zooming in on the data presented on November 2nd 2023 - PICCOLO study in 3L+ PSOC:- settings related question: what is the current unmet medical need in 3rd line PSOC?
According to mgmt, the study met its primary endpoint of ORR clearing the 28% hurdle, the responses at the planned interim analysis were all confirmed, and the study is still ongoing with pts receiving treatment.The company further reported that it expects a 48% or higher ORR at the full update in mid 24.
- 5a. What is the ORR bar in this patient population that you would find clinically meaningful? What is the durability of response that you would like to see here?
- 5b. Could you help us understand the guidance on expected ORR of 48% or higher? How is this modeling done on studies? Would that mean that the assessed responses so far are already at 48%?
- 5c. Which results would indicate that PICCOLO could be used for label expansion?
There are two other PSOC trials:
- Ph2 Trial 420 of Mirv + carbo in 2L + PSOC at all FRa levels (single arm)
- randomized Ph3 GLORIOSA of Mirv + bev vs Bev as maintenance in FRa-high.
Competitive landscape - at ESMO Daiichi Sankyo/MRK reported data on CDH6 ADC in PROC:
- PhI, N=50 patients, 46% ORR (1CR, 22PRs), mPFS=7.9 months (numerically competitive to IMGN ELAHERE PhIII data, 42% ORR, mPFS=5.6months)
- 2 case of Grade5 ILD reported at the 8mg/kg dose (not selected to go forward)
- not clear dose -dependent responses
Is there anything else in ovarian cancer pipeline that you are paying attention to closely?
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