Monday, July 5, 2021

J&J won’t pursue Erleada, Zytiga prostate cancer combo after trial results disappoint


Johnson & Johnson won’t file regulatory submissions for its prostate cancer combo of Erleada and Zytiga after the pair failed to reach key secondary trial goals, including overall patient survival. 

The New Jersey drug giant based its decision on findings from the combo’s phase 3 ACIS study, which were presented at the American Society of Clinical Oncology’s Genitourinary Cancers Symposium in February.

The trial tested J&J’s androgen receptor inhibitor Erleada with its aging prostate cancer med Zytiga and corticosteroid prednisone in patients with chemotherapy-naïve metastatic castration-resistant prostate cancer. The patients had previously received androgen deprivation therapy. 

The trial met its primary endpoint, showing the three-drug combo reduced the risk of radiographic progression or death in patients by 31% over Zytiga and prednisone. But it failed to show “significant benefit” in key secondary endpoints, including life extension, time to chronic opioid use, time to initiation of cytotoxic chemotherapy, and time to pain progression, J&J said.

RELATED: ASCO: J&J’s Erleada extends lives by 14 months in nonmetastatic prostate cancer

Not all is lost, J&J says. The study generated “valuable scientific outcomes and insights in subgroups of patients” which warrant further investigation, Janssen’s Kiran Patel, vice president of clinical development, solid tumors, said in a statement.

“These data will be important in informing future programs in our pipeline, as we look to build upon our leadership and commitment in bringing transformational therapies to patients diagnosed with prostate cancer,” Patel added.

After generics launched in late 2018, copycats have been weighing on revenues for J&J’s Zytiga. The med generated $50 million in U.S. sales during the first quarter, J&J reported Tuesday, a 64% drop compared with the same quarter last year. 

RELATED: Fighting for market share, J&J expects last year’s copycat pain to ‘bleed into 2020’

Meanwhile, sales for Erleada are on the rise. The company reported that U.S. sales of Erleada reached $171 million in the first quarter, a 44% increase compared with the same period last year.



Source link

Stay Connected

1,605FansLike
11,000FollowersFollow
342FollowersFollow
775FollowersFollow

Latest Articles

Covid’s second wave proves lethal for pregnant women

At SVP Hospital in Ahmedabad – one of the major Covid-19 hospitals of the city – 148 pregnant women with Covid-19 infection were admitted...

7 Tips to Keep Your Gut Healthy

This is common to say health (and illness) starts in your gut. If you have poor gut health, you’ll experience anything from wrinkled skin, to...

SII making first batch of Covovax: Poonawalla

The first batch of Covovax, a Covid-19 vaccine developed by Novavax Inc, is being manufactured at the Serum Institute of India's Pune facility, SII...

Sputnik V is safest among all Covid-19 vaccines, no deaths recorded: Buenos Aires study

A study by the Buenos Aires Ministry of Health to monitor the safety of the Sputnik V vaccine against Covid-19 confirmed on Thursday that...

Telangana caps Covid treatment charges in private hospitals

Hyderabad: The government of Telangana on Wednesday issued orders fixing treatment and investigation charges for Covid-19 in private hospitals.The state government, which had capped...