Iberdomide

Actress and director Mariska Hargitay lost her father, actor Mickey Hargitay, to multiple myeloma in 2006. Twenty-six years of chasing New York City sex crimes as the face of “Law & Order: Special Victims Unit” has prepared award-winning actress Mariska Hargitay to put on her own detective hat in her next role: “Investigating Myeloma” with Bristol Myers Squibb. Hargitay, who plays kind-hearted police captain Olivia Benson on NBC's “SVU,” has a personal connection to this case in her late father, actor and bodybuilder Mickey Hargitay, who passed away in 2006 from multiple myeloma. Twenty years later, his daughter still has “questions about the disease that brought down this pillar in my life,” she said in a BMS press release. “My father was and remains my hero,” Hargitay said. “This campaign is my chance to honor my dad, answer my questions about myeloma, and shine a light on CELMoD research, a remarkable area of scientific inquiry that has emerged since his death and is renewing hope for patients and their loved ones.”With its cereblon E3 ligase modulation (CELMoD) approach, BMS aims to crack the multiple myeloma case by selectively engaging key proteins involved in the disease to stimulate the immune system and promote cancer cell killing. At the recent American Society of Clinical Oncology annual meeting, the company showed that its CELMoD candidate, mezigdomide, more than doubled progression-free survival in patients with relapsed or refractory multiple myeloma, an “incredibly exciting” result, as BMS’ head of late-stage development for hematology, oncology and cell therapy, Anne Kerber, M.D., told Fierce Biotech. The trial weighed the use of mezigdomide in combination with Amgen’s Kyprolis and dexamethasone versus that pair alone.Aside from mezigdomide, the company is advancing CELMoD agent iberdomide in a treatment regimen for relapsed or refractory multiple myeloma. With an FDA decision slated for August, iberdomide has the potential to be the first approved treatment offering in the CELMoD drug class. As for Hargitay, she recalls noticing something “might be wrong” with her father’s health at her 2004 wedding, when he seemed “unusually tired,” according to the BMS release. While he approached his eventual diagnosis with a “positive attitude” and “fought with everything he had until the end,” Hargitay’s personal journey looking back on her father’s story is the backbone of “Investigating Myeloma,” showcasing the “critical need for continued scientific investigation,” BMS explains. Her story spoke to BMS’ own SVP of oncology commercialization, Monica Shaw, M.D., who also lost her father to multiple myeloma.“I had trained as a physician but was working in industry at the time of his diagnosis, and I remember how difficult it was to truly understand what his options were and how to access them,” Shaw said. “No patient or family should have to navigate that complexity on their own. That experience fuels my commitment to expanding access, simplifying the journey for patients, and accelerating awareness of new scientific approaches—like CELMoD research—that have the potential to make a meaningful difference for patients living with multiple myeloma.” In BMS’ dedicated Investigating Myeloma campaign web page, Hargitay looks back on her father’s life and disease journey in a three-minute video that sees the actress digging through boxes of childhood photos and documents, pinned to a detective-style investigation board similar to those often used by Hargitay in the long-running “Law & Order” franchise. “There were so many unanswered questions,” she said in the video. “I just didn’t understand how it could happen to him.” Hargitay goes on to highlight BMS’ CelMoD research, which focuses on “trying to understand more about this very complex disease,” she says.“My hope is that by sharing my father’s story and highlighting CELMoD research that I can help educate on multiple myeloma and inspire other people that are impacted by this disease to not give up,” Hargitay explains. The video ends with text prompting viewers to “uncover more” by visiting the campaign website, which offers BMS resources on myeloma and features another company video dedicated to “uncovering CELMoD research.” 

CELMoD drugs, which have not yet had an FDA approval, are similar to the pharma\'s existing protein degraders Revlimid and Pomalyst.\n Bristol Myers Squibb may be leading the way when it comes to pursuing cereblon E3 ligase modulator (CELMoD) drugs, but today, the pharma is standing tall. BMS shared data at the American Society of Clinical Oncology annual meeting on Friday that demonstrated that its CELMoD candidate mezigdomide more than doubled progression-free survival in patients with relapsed or refractory multiple myeloma.The data come from the 479 patients analyzed in the phase 3 SUCCESSOR-2 trial testing mezigdomide in combination with Amgen’s Kyprolis and dexamethasone versus that pair alone.Patients in the mezigdomide arm lived without disease progression for an average of 18 months, compared to 8.3 months for those given just Kyprolis and dexamethasone. Overall, the mezigdomide regimen cut the risk of disease progression or death by 52%, BMS reported in a May 29 release.The pharma had previously announced that the trial hit its primary endpoint of progression-free survival, but is only now divulging the numbers behind the win.“It\'s incredibly exciting,” Anne Kerber, M.D., BMS’ head of late-stage development for hematology, oncology and cell therapy, told Fierce Biotech in an interview ahead of ASCO. Kerber highlighted the fact that mezigdomide managed to nearly triple the complete response rate to 26.7% compared to 8.9% in the control arm, despite patients in the study being heavily pretreated.It’s still too early to draw conclusions about overall survival rates, Kerber added, but so far it seems mezigdomide is having an effect there as well. “The overall survival data is immature, but we already start [to] see the curves separate at this very early point in time,” she told Fierce.Side effects were worse in patients treated with mezigdomide, with 83.7% of patients reporting grade 3 or 4 adverse events related to treatment in the mezigdomide arm vs 56.5% in the control cohort. This safety profile is consistent with prior trials, according to Kerber, and side effects were “nothing unexpected and very well manageable.”BMS plans to discuss the data with the FDA at some point in the future, Kerber said. The regulator is already considering another of the drugmaker’s CELMoD candidates, iberdomide, for approval in the same indication, with a decision expected by August 17.CELMoD drugs, which have not yet had an FDA approval, are similar to the pharma\'s approved protein degraders thalidomide, Revlimid and Pomalyst. In multiple myeloma, they are designed to target transcription factors called Ikaros and Aiolos, which the cancer relies on.“These compelling data further validate our targeted protein degradation platform, and cereblon as a critical therapeutic target in multiple myeloma,” Cristian Massacesi, M.D., BMS’ chief medical officer and head of development, said in the release. “Mezigdomide is a very potent, oral CELMoD and we’re committed to bringing it forward as a potential new standard of care for relapsed/refractory multiple myeloma across multiple settings,” Massacesi added.Kerber highlighted to Fierce that some of the patients in the SUCCESSOR-2 study had been previously treated with Revlimid and Pomalyst, but mezigdomide still worked. Mezigdomide is also more potent than iberdomide, but the two pair differently with existing medications, leaving room for both in the myeloma care landscape.Though mezigdomide development is for now focused on later lines of therapy, Kerber said BMS hopes to bring the molecule forward in the treatment paradigm in the same way iberdomide has been. “The concept in multiple myeloma is really to bring up your best treatments into as early [line] as possible, to really drive very long progression-free survival times,” Kerber said.Meanwhile, another CELMoD drug, golcadomide, is in the works for patients newly diagnosed with B-cell lymphoma, with fresh data also being shared at this month’s ASCO event.