Promising Phase 1 Results for Johnson & Johnson's New Multiple Myeloma Treatment

Johnson & Johnson's Trispecific Antibody Brings Hope for Multiple Myeloma Patients

Recently, Johnson & Johnson disclosed encouraging findings from the initial Phase 1 trials of their investigational trispecific antibody, JNJ-79635322 (JNJ-5322), aimed at treating patients with relapsed or refractory multiple myeloma. Presented during the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, these results underscore a significant leap in immunotherapy for this challenging condition.

Overview of the Study

The Phase 1 study included 126 heavily pretreated patients suffering from relapsed multiple myeloma, and highlighted a remarkable overall response rate (ORR) of 86.1% for patients who received the recommended Phase 2 dose (RP2D) of JNJ-5322. In a particularly promising subgroup of 27 patients who had not yet received therapies targeting B-cell maturation antigen (BCMA) or GPRC5D, the ORR hit 100% at the RP2D. This speaks volumes about the drug's potential effectiveness.

JNJ-5322 employs a unique structure that allows it to bind simultaneously to three different targets: BCMA and GPRC5D on myeloma cells, along with CD3 on T-cells. This distinctive mechanism is specifically designed to tackle tumor heterogeneity and inhibit the development of resistance, a common hurdle in treating cancers like multiple myeloma.

Study Design and Results

Participants in the trial were given escalating doses of JNJ-5322, with a median follow-up of 8.2 months. The RP2D involved a step-up dose initially and subsequent monthly dosing. According to Dr. Niels van de Donk from VU University Medical Center in the Netherlands, the findings reflect a promising safety profile coupled with the drug's efficacy. Dr. Donk emphasizes the importance of this endeavor in redefining treatment possibilities for patients with relapsed forms of the disease.

Despite the encouraging results, some adverse effects were observed. Cytokine release syndrome (CRS) was the most frequent, reported by 59% of patients, although none were rated Grade 3 or higher. Moreover, 28% experienced more severe infections. Notably, there were reports of treatment emergent deaths, although these incidents highlight the importance of ongoing monitoring in future studies.

Outlook for the Future

As Johnson & Johnson prepares for further Phase 2 and Phase 3 studies, the preliminary data paints a favorable picture for both efficacy and safety, potentially yielding another robust treatment option for clinicians. Dr. Jordan Schecter, Vice President of Research and Development for Multiple Myeloma, expressed optimism over the progress made. He emphasized the company’s commitment to innovate within oncology and improve outcomes for patients facing this challenging diagnosis.

About Multiple Myeloma

Multiple myeloma is characterized by the uncontrolled growth of plasma cells in the bone marrow, leading to a range of symptoms, including bone pain, fatigue, and increased infections. This form of blood cancer remains incurable, with more than 35,000 American diagnoses expected in 2024 alone, highlighting the urgent need for effective therapy options.

Johnson & Johnson's exciting developments in this area provide a newfound hope for many patients and families affected by multiple myeloma. As research advances, the healthcare community remains enthusiastic about the possibilities presented by innovative treatments like JNJ-5322.