NEW BRUNSWICK (dpa-AFX) - Johnson & Johnson (JNJ) reported encouraging first-in-human Phase 1 results for the investigational combination of pasritamig and JNJ-9401, two bispecific antibodies designed to work together to enhance the immune system's ability to target advanced prostate cancer.
At the recommended dosing regimen, 73% of treated patients achieved a prostate-specific antigen (PSA) reduction of at least 50%, while 47% experienced deep PSA declines of 90% or more. PSA is a key biomarker used to assess prostate cancer activity and treatment response.
The combination marks the first clinically evaluated dual-tumor-antigen-targeted bispecific antibody regimen in prostate cancer. The therapy simultaneously targets kallikrein-related peptidase 2 (KLK2) and prostate-specific membrane antigen (PSMA), delivering complementary T-cell activation signals aimed at improving immune cell recognition and elimination of cancer cells.
Notably, all seven patients who achieved PSA reductions of at least 90% remained on treatment for more than six months without disease progression, highlighting the durability of the responses observed to date. The regimen also demonstrated a favorable safety profile in the early-stage study, with no Grade 3 or higher treatment-related adverse events reported.
The findings suggest the potential for outpatient administration and support continued development of the combination strategy. The regimen is currently being evaluated in the ongoing Phase 3 KLK2-comPAS trial, which is assessing whether adding JNJ-9401 to pasritamig can improve outcomes for patients with metastatic castration-resistant prostate cancer (mCRPC), an advanced form of the disease with significant unmet medical need.
The positive Phase 1 data strengthen the case for dual-targeted bispecific antibodies as a potential new treatment approach in prostate cancer and provide early evidence that simultaneous targeting of KLK2 and PSMA may deliver meaningful and durable clinical benefit for patients with advanced disease.
JNJ closed Friday's regular trading at $276.22 up $3.90 or 1.43%.
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