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Tempus AI is expanding its partnership with Verastem Oncology to develop a companion diagnostic (CDx) for the latter’s KRAS-mutant recurrent low-grade serous ovarian cancer (LGSOC) combination treatment.
Tempus completed confirmatory testing of biopharma Verastem’s avutometinib and defactinib combo treatment in the biopharma’s Phase II RAMP-201 (NCT04625270) clinical trial evaluating the therapy’s efficacy for KRAS-mutated recurrent LGSOC.
Verastem’s trial results demonstrated an overall response rate (ORR) to the combination treatment of 44% among patients with KRAS mutant LGSOC, and 17% ORR for patients with KRAS wild-type.
Professor Susana Banerjee, consultant medical oncologist at the Royal Marsden NHS Foundation Trust and team leader in Women’s Cancers at the Institute of Cancer Research and the study’s lead global investigator, called the ORR “significant” during a presentation on the trial results at the International Gynaecologic Cancer Society (IGCS) 2024 Annual Meeting.
She said: “These updated results confirm the potential of this new combination therapy to change practice and be the new standard for care for recurrent low-grade serous ovarian cancer, which previously had limited effective treatment options.”
Verastem’s Phase II results formed the basis of the US Food and Drug Administration’s (FDA) accelerated approval of the combination in KRAS-mutated recurrent LGSOC on 8 May.
Approved by the FDA in 2023, Tempus’ xT CDx assay is an in vitro diagnostic (ICD) based on next-generation sequencing (NGS). The assay is designed to detect substitutions of single-nucleotide variants (SNVs) and multi-nucleotide variants (MNVs) and insertion and deletion alterations (INDELs) in 648 genes.
The xT will be used to prospectively assess KRAS status in patients with recurrent LGSOC to group patients into KRAS-mutation or KRAS-wild type cohorts for analysis in the primary and secondary endpoints of Verastem’s Phase III RAMP-301 trial (NCT06072781).
Verastem's chief medical officer Dr John Hayslip commented: "Collaborating with Tempus to evaluate KRAS 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."
"Tempus partners with Verastem for companion diagnostic development" was originally created and published by Medical Device Network, a GlobalData owned brand.