Merck aims for prostate cancer dominance with 3 new phase 3 Keytruda studies

[JLS1]

Interesting and encouraging, and includes links to other encouraging trials :

Merck aims for prostate cancer dominance with 3 new phase 3 Keytruda studies

by Carly Helfand | Feb 14, 2019 11:50am

fiercepharma.com/marketing/...

"RELATED: AstraZeneca pioneer Lynparza scores with Zytiga combo in prostate cancer"

"RELATED: With Clovis team-up, Bristol-Myers' Opdivo eyes dynamic-duo attack on a trio of cancers"

If Merck & Co. gets its way, it won’t be long before the prostate cancer treatment landscape looks pretty different.

After fielding promising early results for immuno-oncology star Keytruda in metastatic, castration-resistant forms of the disease, the New Jersey drugmaker is adding a trio of late-stage studies to its Keytruda program, hoping they'll deliver some combo approvals.

Merck will run phase 3 studies testing its standout drug in tandem with Lynparza, the PARP inhibitor it shares with AstraZeneca; in a cocktail containing the chemotherapy docetaxel and steroid prednisone; and alongside Xtandi, a hot prostate cancer drug from Pfizer and Astellas.

Conference

The 13th Annual Digital Pharma East

Digital Pharma East returns to the Pennsylvania Convention Center September 17–20, bringing together over 1000 attendees from biotech and pharma, to better understand how to present business plans, justify budget and innovation, and de-risk proposals getting shut down — essentially, understand how they can return to the office and become champions for their internal digital needs. Join us and save 15% off standard rates when you register with Discount Code DPE19Fierce.

Register Today

The move comes on the back of positive data from the phase 1b/2 Keynote-365 trial that Merck trotted out Thursday morning. In the cohort of patients receiving the Keytruda-Lynparza duo, 12% recorded a decrease of 50% or more in prostatic specific antigen, a protein whose levels are often elevated in men with prostate cancer. The Keytruda-docetaxel-prednisone regimen produced a PSA response rate of 31%, while the Keytruda-Xtandi posted a rate of 26%.

RELATED: AstraZeneca pioneer Lynparza scores with Zytiga combo in prostate cancer

In each of the groups, at the six-month mark, more than 70% of patients had survived, and in the docetaxel-prednisone and Xtandi groups, more than 90% of patients were still alive.

Of course, Merck isn’t the only company that’s testing its PD-1/PD-L1 drug in prostate cancer—or its PARP inhibitor, for that matter. In 2017, archrival Bristol-Myers Squibb teamed up with PARP drugmaker Clovis Oncology for a phase two prostate cancer test of Opdivo and Rubraca, and BMS has Opdivo going in a number of other prostate cancer trials, too.

RELATED: With Clovis team-up, Bristol-Myers' Opdivo eyes dynamic-duo attack on a trio of cancers

And Thursday, Johnson & Johnson trumpeted phase 2 data showing that Zejula—the third major player in the PARP class, and a drug to which it owns the rights in prostate cancer—could provoke a response in about 40% of mCRPC patients with BRCA mutations.

But Merck is aiming to show up its rivals. The addition of the three new studies will give it the largest development program with a PD-1/PD-L1 drug in prostate cancer, and it’ll also make it the only drugmaker to feature overall survival—considered the gold standard in cancer trials—as a coprimary endpoint through phase 3 trials.

Read more on

prostate cancer clinical trial PD-1/L1 checkpoint inhibitors immuno-oncology PARP inhibitors Merck & Co. Lynparza Xtandi Zytiga Johnson & Johnson Keytruda

[Zensailor]

What can I help you with?

[j-o-h-n]

Thank you for the info.....

Good Luck, Good Health and Good Humor.

j-o-h-n Saturday 08/10/2019 1:03 PM DST

[snoraste]

Good read.

[monte1111]

Nice to know there may be something ready in the wings when Xtandi fails.

[Magnus1964]

Great information.

[blueCello]

My husband had genetic testing for keytruda and he did not, unfortunately, have the right genetic markers for his metastatic stage four prostate cancer. Not good to give people hope if they haven't been tested properly. I've seen Lutetium combinations with penzolimab or something close to that name which is Keytruda. Worked for Jimmy Carter. I hope it works for you.

[AlanLawrenson]

Keytruda even in combo has efficacy in only a small number of men. However, every 'breakthrough' helps a % of PCa sufferers. More than 1000 clinical trials underway worldwide into PCa. Unbelievable effort. I am in final phase of writing a new PCa book. Every day I have to add to the data to be included. In fact, its just about impossible to keep up with the advances being made.