Tempus and Verastem Partner to Develop Companion Diagnostic for First FDA-Approved KRAS-Mutant LGSOC Treatment
核心洞察
Tempus AI and Verastem Oncology have announced a collaboration to develop a companion diagnostic test for the recently FDA-approved combination therapy of avutometinib and defactinib for KRAS (搜索)-mutated recurrent low-grade serous ovarian cancer (搜索).
The partnership builds on Tempus' confirmatory testing in Verastem's Phase 2 RAMP-201 clinical trial, with their FDA-approved xT CDx assay now being used as an investigational assay in the global Phase 3 RAMP-301 trial.
Low-grade serous ovarian cancer (搜索) (LGSOC (搜索)) is a rare form affecting younger women, accounting for 6-10% of serous ovarian cancers, with historically poor response to chemotherapy and limited treatment options.
Tempus AI, Inc. (NASDAQ: TEM) and Verastem Oncology (Nasdaq: VSTM) have announced a strategic collaboration to develop a companion diagnostic (CDx) test for the first-ever FDA-approved treatment for KRAS (搜索)-mutated recurrent low-grade serous ovarian cancer (搜索) (LGSOC (搜索)).
The partnership follows the recent accelerated FDA approval of Verastem's combination therapy of avutometinib and defactinib for treating KRAS (搜索)-mutated recurrent LGSOC (搜索). Tempus had previously completed confirmatory testing in Verastem's Phase 2 RAMP-201 clinical trial, which evaluated this combination therapy and formed the basis for the FDA approval.
Addressing a Significant Unmet Need
LGSOC (搜索) is a rare form of ovarian cancer that disproportionately affects younger women. It accounts for approximately 6% to 10% of serous ovarian cancers and is characterized by high recurrence rates and poor response to conventional chemotherapy.
"We look forward to continuing to work with Verastem to pursue an unmet need for patients with LGSOC (搜索), who, until now, had very few treatment options," said Mike Yasiejko, Executive Vice President and General Manager, Genomics, at Tempus.
The Role of Precision Diagnostics
Tempus' FDA-approved xT CDx assay is currently being leveraged as an investigational assay in Verastem's global Phase 3 RAMP-301 clinical trial. The assay prospectively assesses KRAS (搜索) mutation status in patients with recurrent LGSOC (搜索), grouping them into KRAS-mutation or KRAS-wild type cohorts for analysis in the primary and secondary endpoints of the study.
The xT CDx is a qualitative Next Generation Sequencing (NGS)-based in vitro diagnostic device that can detect various genetic alterations in 648 genes, as well as microsatellite instability (MSI) status, using DNA isolated from tumor tissue specimens and matched normal samples.
Dr. John Hayslip, Chief Medical Officer of Verastem Oncology, emphasized the importance of this collaboration: "Collaborating with Tempus to evaluate KRAS (搜索) mutation status using the xT assay was an important component of the RAMP-201 clinical trial. Continuing our collaboration to fully develop a CDx assay is part of our post-marketing commitment to the FDA for our recent accelerated approval of avutometinib plus defactinib and is a critical step in bringing targeted therapies to patients with recurrent KRAS-mutant LGSOC (搜索)."
Advancing Precision Medicine
This collaboration represents a significant advancement in precision medicine for ovarian cancer patients. By identifying specific genetic mutations that drive cancer growth, healthcare providers can better select patients who are most likely to benefit from targeted therapies.
Tempus, a technology company focused on applying artificial intelligence in healthcare, maintains one of the world's largest libraries of multimodal data. Their operating system makes this data accessible and useful, providing AI-enabled precision medicine solutions to physicians for personalized patient care.
The development of this companion diagnostic aligns with the growing trend toward personalized cancer treatments that target specific genetic alterations, potentially improving outcomes while minimizing unnecessary treatments for patients unlikely to respond.