Merck’s KEYNOTE-522 Success; BMS Licenses PRX019, Prothena Gets $80M

 Merck’s Phase III KEYNOTE-522 study has achieved its overall survival (OS) goal, marking a significant advancement in the treatment of high-risk early-stage triple-negative breast cancer (TNBC) with KEYTRUDA (pembrolizumab) combined with chemotherapy. Concurrently, Bristol-Myers Squibb (BMS) has secured an exclusive global license for Prothena’s neurodegenerative drug PRX019, highlighting a growing partnership aimed at tackling neurodegenerative diseases.

Merck KEYNOTE-522 Study Reaches OS Goal in High-Risk Early-Stage Triple-Negative Breast Cancer

Merck (NYSE: MRK) has achieved a significant milestone in the fight against high-risk early-stage triple-negative breast cancer (TNBC). The company announced that its Phase III KEYNOTE-522 study met its overall survival (OS) endpoint. This breakthrough highlights the effectiveness of KEYTRUDA (pembrolizumab) combined with chemotherapy.

The study, targeting patients with high-risk early-stage TNBC, evaluated the efficacy of combining KEYTRUDA with chemotherapy as a preoperative (neoadjuvant) treatment, followed by single-agent (adjuvant) treatment post-surgery. According to a pre-specified interim analysis conducted by an independent data monitoring committee, KEYTRUDA demonstrated a statistically significant and clinically meaningful improvement in OS compared to preoperative chemotherapy alone. The safety profile of KEYTRUDA was consistent with previous studies, and no new safety concerns were observed.

KEYNOTE-522 is now the fourth KEYTRUDA-based treatment to show improved OS in early-stage cancer, joining KEYNOTE-A18 in cervical cancer, KEYNOTE-671 in non-small cell lung cancer, and KEYNOTE-564 in renal cell carcinoma. In the United States, KEYTRUDA has two approved indications in TNBC: as neoadjuvant therapy combined with chemotherapy and continued as monotherapy post-surgery for patients with high-risk early-stage TNBC, and in combination with chemotherapy for the treatment of local recurrence or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as identified by an FDA-approved test.

Dr. Gursel Aktan, vice president of global clinical development at Merck, stated, “This is an important milestone. For the first time, an immunotherapy-based treatment regimen has significantly improved overall survival in patients with high-risk early-stage triple-negative breast cancer. Based on the pathological complete response and event-free survival results obtained, these results will allow regulatory agencies in more countries to approve this therapy.”

Bristol-Myers Squibb selects exclusive global license for new neurodegeneration drug, Prothena receives US$80 million

Biotech company Prothena (NASDAQ: PRTA) announced that Bristol Myers Squibb (BMS) has obtained an exclusive global license for PRX019, marking a significant collaboration in the field of neurodegenerative disease treatment. The U.S. Food and Drug Administration (FDA) approved the Investigational New Drug (IND) application for PRX019 in December 2023. This agreement highlights the growing partnership between Prothena and BMS in developing innovative therapies.

BMS will pay $80 million for the global license of PRX019. Focusing on protein dysregulation, including AL or ATTR amyloidosis, Alzheimer’s, Parkinson’s, and other neurodegenerative diseases, they plan to initiate a Phase 1 clinical trial of PRX019 by the end of 2024. While the specific target of PRX019 has not been disclosed, the drug shows potential for treating neurodegenerative diseases.

Under the global licensing agreement, Prothena will also be eligible to receive additional development, regulatory, and sales milestone payments totaling up to $617.5 million, along with tiered net sales royalties.

Dr. Gene Kinney, President and Chief Executive Officer of Prothena, expressed enthusiasm for the collaboration, stating, “Our agreement with Bristol Myers Squibb has led to two clinical development programs, supporting efforts to advance potential treatments for neurodegenerative diseases. We are excited about BMS’s selection of PRX019 and the exclusive global authorization. With the IND in effect and the agreement in place, we are on track to launch Phase 1 clinical trials by the end of 2024.”

Richard Hargreaves, Senior Vice President and Head of BMS’ Neuroscience Research Center, added, “Our expanding research and development efforts in neuroscience demonstrate our commitment to addressing unmet medical needs. Advancing PRX019 through our collaboration with Prothena as a potential disease-modifying treatment option for patients with neurodegenerative diseases and adding PRX019 to BMS’s neuroscience therapeutics pipeline is a significant step forward.”

ASCO 2024’s Breakthroughs in Oncology and Neurodegenerative Disease Treatment

Merck’s KEYNOTE-522 study’s success demonstrates the potential of immunotherapy in improving survival outcomes for patients with high-risk early-stage TNBC, potentially influencing future regulatory approvals. Meanwhile, BMS’s acquisition of the PRX019 license and its planned Phase 1 clinical trials by Prothena signify a commitment to advancing treatments for neurodegenerative diseases. These developments, along with many others, were prominently showcased at ASCO 2024, highlighting the event’s diverse array of groundbreaking topics.

Author

Bernice Lottering