Apalutamide Regimen Cuts Metastasis Risk 20%; Amivantamab Shows 42% Response
JNJ•Johnson & Johnson’s PROTEUS Phase 3 trial showed apalutamide plus androgen deprivation therapy given six months before and after surgery cut the risk of prostate cancer metastasis or death by 20%, raised pathologic complete response/minimal residual disease to 8.9% versus 1.0%, and extended time to subsequent therapy to 74.2 months. In the Phase 1b/2 OrigAMI-4 study of subcutaneous amivantamab and hyaluronidase-lpuj in recurrent or metastatic head and neck squamous cell carcinoma, overall response rate was 42% with 15% complete responses and median duration of response not yet reached at 11.8-month follow-up, prompting a supplemental license application to FDA.
1. PROTEUS Phase 3 Study Results
PROTEUS is a randomized Phase 3 study of apalutamide plus androgen deprivation therapy before and after radical prostatectomy in 2,109 patients with high-risk localized or locally advanced prostate cancer. At a median follow-up of 61.7 months, the combination achieved an 8.9% pathologic complete response/minimal residual disease rate versus 1.0% with hormone therapy alone (odds ratio 10.17; p<0.0001), reduced the risk of metastasis or death by 20% (hazard ratio 0.80; p=0.02), and extended median time to subsequent therapy to 74.2 months compared with 41.5 months.
2. OrigAMI-4 Head and Neck Cancer Trial
OrigAMI-4 evaluated subcutaneous amivantamab with hyaluronidase-lpuj as monotherapy in 102 patients with recurrent or metastatic head and neck squamous cell carcinoma previously treated with immunotherapy and platinum-based chemotherapy. Confirmed overall response rate was 42% with 15% achieving complete responses, median duration of response not reached at 11.8-month follow-up, and a supplemental license application has been submitted to the FDA for this indication.
