ASCO 26: Big win for Erleada in perioperative prostate cancer

ASCO's Sunday plenary session will open with results of a 2,109-person global prostate cancer study that showed adding Johnson & Johnson's Erleada (apalutamide) to the treatment regimen for patients undergoing radical prostatectomy increased the likelihood of a complete or nearly complete response ninefold (from 1% in the control group to 8.9% in the treatment group).

Patients also had a 29% lower risk of recurrence, a 20% lower risk of metastasis, and a median survival of 57.1 months compared to 38.4 months in the control group.

"The global burden of prostate cancer is projected to nearly double from 1.5 million newly diagnosed cases annually to almost 3 million by 2040," primary investogator Dr Mary Ellen Taprin said in a press briefing at the conference yesterday, noting that about 60,000 of those cases are localised, high-risk cancers. "Patients with localised high-risk prostate cancer have an increased risk of recurrence and death despite the current standard treatment options [of] prostatectomy or a combination of radiation androgen deprivation therapy (ADT). And despite refinements in prostatectomy over the recent years, there is a very high relapse rate for patients who start prostatectomy, and those relapse rates can approach 50 to 70% depending on their baseline patient characteristics. ... So this is a serious unmet need for prostate cancer."

The study looked at adding apalutamide, an androgen pathway receptor inhibitor, to an existing standard of care, surgery plus ADT. The drug was administered for six months both before and after the surgery.

"We are talking here about deeper responses, decreasing risk of progression, really having long-term control of the disease," Dr Henar Hevia, Johnson & Johnson's European therapeutic area head for solid tumours, told pharmaphorum. "This is super important for patients, and really delaying the need of additional treatments for these patients. Apalutamide is potentially going to set a new standard in this type of patient."

While Erleada has been in the market for a number of years, it's currently used in metastatic settings.

"This is the first time and the earliest that we've ever seen a product like apalutamide, which is called an ARPI, that is being used in a setting perioperative to the radical prostatectomy," Carolyn Sousa, head of commercial strategy for solid tumors in EMEA for Johnson & Johnson, told pharmaphorum. "So it's the earliest we've ever treated systemically with surgery. And it's the first data that we will have in this type of setting. It's a real opportunity that if we act early, we can get much better outcomes for these patients."

The trial is also notable for its size and scope -- more than 2,000 patients across 118 hospitals and 18 countries, the largest trial ever in localised prostate cancer.

"This is a very important study in that we've been for decades trying to combine systemic therapy with surgery. In general, systemic therapy has never made surgery for high-risk localised prostate cancer better," said ASCO expert Dr. William Oh at the press briefing. "It has sometimes reduced the burden of disease in the prostate, but it's never had a meaningful long-term outcome."

Oh did note some limitations that future trials will need to mitigate, namely that the study did not compare its regimen to ADT plus radiation therapy, another common standard of care, nor did it look at the adjuvant therapy with surgery alone.