J&J's Erleada cuts prostate cancer recurrence or death risk by 62% in a substudy as Moderna and Merck fall on melanoma data leak

Johnson & Johnson (JNJ) said Erleada (apalutamide) plus hormone therapy, given for six cycles before and six after radical prostatectomy, reduced the risk of recurrence or death by 62% versus surgery alone in newly diagnosed high-risk localised or locally advanced prostate cancer (hazard ratio 0.38, 95% CI 0.26-0.55). The result comes from a Phase 3 PROTEUS substudy presented at ESMO in Madrid on Oct. 24.

The comparison has limits. The open-label study randomised 408 patients, 102 to apalutamide and 306 to surgery alone, and the endpoint is event-free survival, not overall survival. At three years 63% of the apalutamide arm was event-free versus 41.4%. Grade 3 or 4 adverse events occurred in 31% versus 22%. The regimen is not approved for this use, and overall survival follow-up is ongoing.

Separately, data from Moderna (MRNA) and Merck's (MRK) Phase 3 INTerpath-001 melanoma trial appeared on a medical news site around 12:30 p.m. ET on Oct. 22, two days before the embargoed ESMO presentation, and were taken down. Moderna fell as much as roughly 25% intraday and Merck as much as 3.9%. Merck's release later that afternoon put the 42% reduction in recurrence or death at a hazard ratio of 0.58 with Keytruda alone as the comparator. Moderna was down another 4% in morning trading on Oct. 23 after an 18% drop the prior session.

Oncologists praised the data, a disconnect with Wall Street. Expectations differed by source: UBS reportedly wanted a hazard ratio near 0.65 or better, while one commentator cited a hoped-for range of 0.50 to 0.59. Nanobiotix also reported 24 heavily pretreated advanced melanoma patients on JNJ-1900 (NBTXR3), licensed to a J&J unit, with a 41.7% response rate and 75% disease control.

Watch for any J&J regulatory plans for the Erleada setting, overall survival data, and the regulatory path Merck says it is discussing for intismeran.