ImmunoGen ( IMGN Quick Quote IMGN - Free Report) provided an update on its pivotal phase II CADENZA study, evaluating its antibody-drug conjugate (ADC), pivekimab sunirine, in blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare and aggressive form of blood cancer.
The study primarily evaluated the efficacy of pivekimab in 20 front-line BPDCN patients, including de novo and patients with prior or concomitant hematologic malignancy (PCHM).
The preliminary data showed significant activity and favorable tolerability in the de-novo patients and those with PCHM.
ImmunoGen reported data from the first 10 patients of the study, including four de novo and six PCHM patients. Two out of the four de novo patients achieved complete response/ clinical complete response (CR/CRc), while four out of the six PCHM patients achieved a CR/CRc/complete response with partial hematologic recovery (CRh)
However, following a type B meeting with the FDA, ImmunoGen is now updating the study to focus onefficacy analysis in just de novo BPDCN patients with the primary endpoint of CR/CRc. The study’s secondary endpoint is the duration for which the CR/CRc is maintained in the patients.
The company will enroll 20 de novo patients for the efficacy analysis. To date, ImmunoGen has enrolled six de novo BPDCN patients in the CADENZA study.
Given the rarity of the disease, the company expects complete results from the de novo patient study by 2024.
ImmunoGen will also continue to enroll PCHM patients to evaluate the potential of pivekimab in this population. For the study on PCHM patients, achieving complete response with hematologic recovery (CRh), even though it is not the study’s primary endpoint, can also be an important clinical benefit.
Shares of ImmunoGen have declined 21.7% in the year-to-date period compared with the
industry’s fall of 24.3%. Image Source: Zacks Investment Research
Investors must note that ImmunoGen’s lead pipeline candidate mirvetuximab soravtansine is being developed as a single-agent therapy for platinum-resistant ovarian cancer and in combination regimens for both platinum-resistant and platinum-sensitive diseases. The company’s biologics license application (“BLA”) for mirvetuximab soravtansine, filed in March 2022, was accepted by the FDA for priority review in May. A potential approval for the candidate is expected by Nov 28, 2022.
Zacks Rank and Stocks to Consider
Immunogen currently has a Zacks Rank #3 (Hold).
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