March 1, 2024

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Prostate cancer: Merck/AZ abandons Keytruda-Lynparza combination therapy

Prostate cancer: Merck/AZ abandons Keytruda-Lynparza combination therapy



Prostate cancer: Merck/AZ abandons Keytruda-Lynparza combination therapy.

A few days ago, the combination therapy of Merck’s blockbuster Keytruda and AstraZeneca’s Lynparza failed to outperform the current clinically commonly used anti-androgen therapy in previously treated patients with metastatic castration-resistant prostate cancer (mCRPC). Announced that it will terminate the development of Keytruda-Lynparza combination therapy.


Prostate cancer development setback: Merck/AZ abandons Keytruda-Lynparza combination therapy.


Trial results showed that the Keytruda-Lynparza combination failed to further prolong the lives of mCRPC patients or stop tumor progression compared to Johnson & Johnson Zytiga or Pfizer Xtandi.

To make matters worse, the Merck combination therapy also led to an increased incidence of grade 3-5 drug-related serious side effects in patients with mCRPC.

After the disastrous results of the interim analysis of the Phase 3 Keylynk-010 trial, Merck has decided to follow the recommendations of the independent data monitoring committee and stop the combination therapy development trial as soon as possible.


It is worth noting that the failure of this trial is inevitably surprising. Keytruda and Lynparza have always been considered blockbusters in their respective fields.

Keytruda is the representative drug in the PD-1 field, while Lynparza is the world’s best-selling PARP inhibitor.

In addition, Lynparza alone has previously been approved, based on clinical trial data, in mCRPC patients with homologous recombination repair mutations who have progressed after prior treatment with Xtandi or Zytiga.


Although this prostate cancer combination therapy trial was unsuccessful, Merck has multiple other clinical trials involving Keytruda in prostate cancer and more than 1,000 studies in combination with other drugs in other cancers, including Phase II KEYNOTE-199 and KEYNOTE- 365 trial, Phase III KEYNOTE-641, KEYNOTE-921, and Phase III PROpel trial, among others.


In addition, Merck also announced recently that it has reached a clinical trial cooperation and supply agreement with Imugene, headquartered in Sydney, Australia.

The two parties will test the effect of Imugene’s HER-Vaxx and Keytruda combination therapy in HER-2 positive gastric cancer.

The phase II next HERIZON trial will evaluate the combination of HER-vaxx with chemotherapy or Keytruda in patients with metastatic HER-2/neu-overexpressing gastric or gastroesophageal junction adenocarcinoma who have been previously treated with trastuzumab.

The trial’s primary endpoints are the combination therapy’s safety and response rate, with Imugene sponsoring the cost of the study and Merck providing Keytruda for the duration of the trial.


Meanwhile, Keytruda’s main competitor, Bristol-Myers Squibb Opdivo, is also working with Clovis Oncology’s Rubraca to develop a combination therapy.

Recently announced results of a phase 2 trial called Check Mate 9KD showed a survival benefit of Opdivo and Rubraca in chemotherapy-naïve mCRPC patients with homologous recombination deficiency.

In addition, AstraZeneca itself has been actively developing the efficacy of Lynparza and Imfinzi combination therapy, such as the Phase 3 Duo-O trial is evaluating Lynparza, Imfinzi and Roche Avastin for ovarian cancer.





1、In rare flop, Merck calls it quits on Keytruda-Lynparza combo in prostate cancer

2、Merck Announces Ups and Downs Involving Blockbuster Keytruda

Prostate cancer: Merck/AZ abandons Keytruda-Lynparza combination therapy

(source:internet, reference only)

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