Already on pace to become a blockbuster in just its third full year on the market, Bristol Myers Squibb’s cardiomyopathy drug Camzyos has posted a clinical win that could open the door to use in a younger patient population.
In a phase 3 trial enrolling 44 adolescents ages 12 to 17 with symptomatic obstructive hypertrophic cardiomyopathy (oHCM), the first-in-class cardiac myosin inhibitor met its primary endpoint and achieved statistical significance across several secondary measures tied to meaningful clinical outcomes, the company reported.
Crucially for a pediatric study, Camzyos demonstrated a safety profile in teens that aligned with what has already been observed in adult patients, with no newly identified adverse effects.
The big win arrives less than a year after BMS disclosed disappointing results from a separate phase 3 study of Camzyos in non-obstructive HCM, where the drug failed to outperform placebo on two primary endpoints in patients with a milder form of the disease.
In the latest trial, known as Scout-HCM, Bristol Myers Squibb reported that Camzyos produced a statistically meaningful drop from baseline in Valsalva left ventricular outflow tract (LVOT) gradient at the 28th week compared with placebo, signaling an improvement in LVOT obstruction.
The study also evaluated a range of secondary measures, including LVOT gradients at rest and after exercise, highest oxygen uptake, patient symptoms and overall health status, along with safety and pharmacokinetic outcomes, the company said.
Scout-HCM is designed as a long-term study spanning more than 200 weeks. It begins with a placebo-controlled phase of 28 weeks, followed by a 28-week active-treatment period in which patients initially assigned to placebo transition to Camzyos, and then continues into an open-label extension that can last up to 144 weeks.
The trial stands out as one of the relatively few phase 3 studies in pediatric cardiology to deliver positive results, according to investigator Joseph Rossano, chief of the Division of Cardiology at Children’s Hospital of Philadelphia, who commented on the findings in a company statement.
Rossano said treatment options for adolescents with oHCM remain largely confined to managing symptoms medically or undergoing surgical intervention. Drawing on decades of clinical experience caring for patients in this area, he expressed strong optimism about the possible benefits a therapy like this could offer this patient group should it receive regulatory authorization from the FDA.
The company stated it plans to present detailed trial findings at an upcoming scientific meeting and to review the information directly with regulatory authorities.
Cristian Massacesi, BMS’s CMO and head of development, said Camzyos has fundamentally changed how symptomatic oHCM is treated in adults, noting that more than 20,000 patients have begun therapy in the U.S., and that the company now hopes to similarly reshape care for adolescent patients in clinical practice.
People living with HCM often face breathlessness, fatigue, weakness and difficulty performing everyday physical tasks such as stair climbing, weight lifting or participating in sports activities, which negatively impacts their overall quality of life.
Camzyos Trial Success Paves Way for Adolescent Patient Expansion
The positive outcomes from the Camzyos trial demonstrate meaningful improvements in cardiac function and patient quality of life. BMS plans to submit the trial data to regulators, aiming to expand Camzyos access to adolescents and ensure the therapy meets unmet medical needs in this population.Bristol Myers Squibb (BMS) announced a major clinical milestone as Camzyos demonstrated strong results in a pivotal trial, paving the way for its potential expansion to adolescent patients. The positive trial outcomes reinforce Camzyos’ role as a leading therapy in treating hypertrophic cardiomyopathy and highlight BMS’ commitment to broadening patient access.
The trial results indicate that Camzyos is both safe and effective in younger populations, supporting regulatory filings for adolescent use in the near future. With Camzyos, BMS is poised to address an important gap in pediatric cardiology, offering a new treatment option for adolescents with hypertrophic cardiomyopathy.
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