ImmunoGen (NASDAQ:IMGN)
Blastic plasmacytoid dendritic cell neoplasm (BPDCN) is a rare and aggressive form of blood cancer, and ImmunoGen (NASDAQ:IMGN) updated the status of its main phase II CADENZA research investigating its antibody-drug conjugate (ADC), pivekimab sunirine, in this disease.
Twenty patients with newly diagnosed BPDCN and those with a history or current diagnosis of a hematologic malignancy were enrolled in this trial to determine the effectiveness of pivekimab in the first line of treatment (PCHM).
Initial results indicated substantial efficacy and well-tolerated by both de novo and PCHM patients.
Ten individuals were reported by ImmunoGen, four with de novo and six with PCHM. Two of the four patients with de novo disease obtained a complete response/clinical complete response (CR/CRc), and four of the six with PCHM did as well (CRh)
After a type B meeting with the FDA, ImmunoGen is revising the research to examine efficacy only in individuals diagnosed with de novo BPDCN, using CR/CRc as the primary endpoint. The study’s secondary goal is the number of days that patients can keep their CR/CRc going strong.
Twenty patients will be added to the study as “de novo” cases for the firm to evaluate. Six individuals with newly diagnosed BPDCN have been included in the CADENZA research conducted by ImmunoGen thus far.
ImmunoGen (NASDAQ:IMGN) anticipates having final data from the de novo patient study by 2024 due to the condition’s rarity.
ImmunoGen (NASDAQ:IMGN) will also keep adding PCHM patients to its patient pool to assess pivekimab’s efficacy in this patient subset. However, even if attaining complete response with hematologic recovery (CRh) is not the trial’s primary goal, it can still have significant therapeutic benefits for individuals with PCHM.
ImmunoGen’s (NASDAQ:IMGN) stock price has dropped 21.7% year-to-date, which is lower than the industry’s drop of 24.3%.
Potential investors should know that mirvetuximab soravtansine, ImmunoGen (NASDAQ:IMGN) flagship pipeline candidate, is being studied as a single-agent therapy for platinum-resistant ovarian cancer, as well as in combination regimens for both platinum-resistant and platinum-sensitive illnesses. The FDA accepted the company’s March 2022 biologics license application (“BLA”) for mirvetuximab soravtansine for priority consideration in May of that same year. By November 28, 2022, we should know whether or not this candidate has been accepted.
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Author Shariq Khan 
