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Onconova Therapeutics initiates phase 1/2a study of rigosertib plus nivolumab to treat KRAS+ lung adenocarcinoma

Newtown, Pennsylvania
Wednesday, June 24, 2020, 18:00 Hrs  [IST]

Onconova Therapeutics, a phase 3-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with an initial focus on myelodysplastic syndromes (MDS), announced an investigator-initiated phase 1/2a trial of oral rigosertib plus nivolumab in advanced metastatic KRAS mutated (KRAS+) lung adenocarcinoma has begun enrolling patients.

“Over half of non-small cell lung cancers are classified as lung adenocarcinomas; of these, the largest subset has a KRAS mutation as the predominant genetic driver,” said Dr. Steven Fruchtman, president and CEO, Onconova Therapeutics. “Despite discovering the KRAS mutation over 30 years ago, little progress has been made in KRAS+ directed treatments. The work under Dr. Rajwanth Veluswamy’s leadership at the Icahn School of Medicine is an important step towards determining if rigosertib, as a RAS-mimetic, can change that.”

The investigator-initiated trial is an open-label, dose-escalating phase 1 study followed by a phase 2a dose-expansion phase to study the combination of oral rigosertib and nivolumab in metastatic KRAS+ lung adenocarcinoma patients who have progressed on standard frontline treatment. The study will assess safety and efficacy.

“The novel combination of rigosertib with an anti-PD-1 antibody targets two of the most important oncogenic pathways in cancer biology,” said Dr. Rajwanth Veluswamy, Assistant Professor, Medicine, Hematology and Medical Oncology, Icahn School of Medicine at Mount Sinai. “This study will evaluate the safety and tolerability of this combination in KRAS mutated NSCLC in which patients have failed frontline immunotherapy. The study will explore efficacy of the combination in this common lung cancer subset and will also determine if rigosertib may restore sensitivity to the PD-1 blockade.”

Rigosertib, Onconova’s lead candidate, is a proprietary phase 3 small molecule. A key publication in a preclinical model reported rigosertib’s ability to block cellular signaling by targeting RAS effector pathways. Onconova is currently in the clinical development stage with oral and IV rigosertib, including clinical trials studying single agent IV rigosertib in second-line higher-risk MDS patients (pivotal phase 3 INSPIRE trial) and oral rigosertib plus azacitidine in HMA naive and refractory higher-risk MDS patients (phase 2). Patents covering oral and injectable rigosertib have been issued in the US and are expected to provide coverage until at least 2037.


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