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Merck & Co / MSD has emphasized the project to create Keytruda as an ideal cancer immunotherapy for prostate cancer, thereby reinforcing its already dominant position in lung cancer.
Provided with positive data from Keytruda's KEYNOTE-365 Phase 1b / 2 study (pembrolizumab) in combination with other drugs in patients with metastatic prostate cancer resistant to castration (mCRPC), Merck pursues its goal with three pivotal trials of PD-1 in combination with Lynparza (olaparib), chemotherapy and anti-hormonal drugs.
Prostate cancer is the most common cancer in men, the second most common after bad cancer and a higher incidence than lung cancer, which has boosted Keytruda's sales so far. And while lung cancer is declining in developed markets as the rate of smoking decreases, prostate cancer tends to increase, which is likely due to the aging of the population.
This combination has made prostate cancer an attractive target for drug developers, especially those working on cancer immunotherapies, but the PD-1 and PD-L1 checkpoint inhibitors have largely failed as monotherapy.
The hope now is that the combinations can unleash the potential of cancer immunotherapy in this form of cancer, disrupting the tumor and allowing immune cells to mobilize and penetrate the microenvironment of the tumor .
The KEYNOTE-365 data reported at the ASCO symposium on genitourinary cancers this week showed that, in patients with castration-resistant prostate cancer, Keytruda improved the efficacy of Lynparza, a PARP inhibitor not yet approved the tests – as well as chemotherapy with docetaxel and prednisone and hormonal therapy with the help of Astellas / Pfizer Xtandi (enzalutamide) without increasing the burden of the effects secondary.
In Keytruda Plus Lynparza arm, 12% of patients experienced a 50% or greater reduction in PSA, a high biomarker in prostate cancer. In the meantime, the combination of chemotherapies had a PSA response rate of 31%, compared with 26% for the Keytruda / Xtandi group.
Clinical evaluation criteria also seemed encouraging, with six-month overall survival rates of 73%, 96%, and 91%, respectively, for the three treatment groups.
Roy Baynes of Merck & Co
The data suggests that Keytruda could potentially serve as a "base treatment" for prostate cancer, said Roy Baynes, Chief Medical Officer of Merck. The company believes that its Phase 3 program is the largest in the PD-1 / PD-L1 category in this type of tumor.
Bristol Myers Squibb, rival in the cancer immunotherapy category, reported findings at ASCO GU with its double immunotherapy combination of a PD-1 inhibitor, Opdivo (nivolumab) and a CTLA4 inhibitor, Yervoy (ipilimumab) in CRPC.
An interim badysis of the CheckMate-650 Phase 2 trial revealed an objective response rate (ORR) of 25% in patients who had been treated with first-line hormonal therapy but had not received chemotherapy.
Principal investigator Padmanee Sharma of the MD Anderson Cancer Center in the United States said the findings provided "a strong rationale for the development of a combined immune-control therapy for the treatment of prostate cancer, which is considered a cold tumor with few lymphocytes infiltrating the tumor.
BMS is also testing Opdivo with Rubraca (rucaparib), an inhibitor of PARP from Clovis Oncology, in the treatment of prostate cancer, as well as studies of its drug in combination with chemotherapy and anti-androgens.
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