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Investing.com -- Genmab (NASDAQ:GMAB) has unveiled new data for its cancer drug Rina-S, which is being tested for use in endometrial cancer. This follows promising early results from trials in ovarian cancer, which led to Genmab’s acquisition of ProfoundBio last year.
Rina-S is an antibody-drug conjugate that targets the folate receptor alpha (FRa). The new data is from a dose expansion cohort of the RAINFOL-01 phase II study in patients suffering from advanced or refractory endometrial cancer.
In the study, two doses of the drug were tested, 100 mg/m2 and 120 mg/m2. The objective response rate (ORR) for the lower dose was 50%, while the higher dose had an ORR of 38%. This differs from the ovarian cancer data from last year, which showed a clear dose-response curve favoring the higher dose. Genmab suggests that differences in BMI between the low and high dose cohorts could explain this contrast.
Based on the endometrial cancer data, Genmab plans to proceed with the lower dose. The ORR of 50% at the low dose appears strong when compared with the current standard of care, single agent chemotherapy, which has an ORR of around 16%.
RBC analysts commented that the ORR for Rina-S also appears robust when compared to competing pipeline projects, such as Dato-DXd, which showed an ORR of 28% in data presented at ESMO last year.
Regarding safety, cytopenia, primarily neutropenia, was a very common side effect, with grade 3 or worse severity in around 77% of patients. However, it was generally treatable with GCSF. Two deaths occurred at the high dose, including one case of sepsis, which was considered drug-related. This likely influenced Genmab’s decision to select the lower dose for further development.
Genmab has initiated a phase III trial with Rina-S in second line treatment for platinum resistant ovarian cancer and plans to start a new phase III trial in platinum sensitive ovarian cancer maintenance setting by year-end. Following the encouraging endometrial cancer data, Genmab also plans to launch a phase III trial in the second line setting by year-end.
The company also disclosed plans to test Rina-S in other cancers, including non-small cell lung cancer. A phase II trial in NSCLC is expected to commence by year-end, likely focusing on EGFR mutated cancers.
RBC analysts stated, "We believe Rina-S has blockbuster potential across PROC and endometrial cancer, and these data reinforce that view. We forecast sales of $1.3bn by 2033, but risk adjust at a 65% probability of success."
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