A subset of lung cancer patients who have already undergone treatment with a popular drug may benefit from a combination therapy that include’s Genprex’s experimental therapy Oncoprex. The company recently announced that it has begun a Phase II clinical trial for lung cancer at the University of Texas MD Anderson Cancer Center in Houston, which will pair erlotinib (known by many by its brand name Tarceva®) with Oncoprex, a targeted biologic, in late-stage lung cancer patients.
Genprex believes that two subsets of late-stage lung cancer patients — ones without the EGFR activating mutation and ones who have the EGFR activating mutation whose cancer has progressed after taking erlotinib — may benefit from erlotinib in combination with Oncoprex, since erlotinib has been found in clinical research to be only minimally effective in treating lung cancer patients who do not have the activating EGFR mutation. In addition, even patients with the activating EGFR mutation who respond positively to erlotinib therapy early often become resistant to the therapy.
In order to test Oncoprex’s efficacy in combination with erlotinib, investigators will treat late-stage lung cancer patients who do not have an activating EGFR mutation, and who have already received chemotherapy. The study will also treat patients who have the activating EGFR mutation and who have seen their lung cancer even after being treated with erlotinib.
This is not the first time that Oncoprex has been combined with erlotinib in clinical trials. Previous studies conducted at MD Anderson revealed promising cancer-killing synergy using an Oncoprex-erlotinib combination along with an assortment of other kinase inhibitors (TKIs) including EGFR, AKT, PDGFR, and Src targeted agents.
In terms of safety and tolerability, Oncoprex has already been tested as a single treatment in a phase I safety study, which found that it was satisfactorily tolerated in 32 late-stage lung cancer patients when taken intravenously, with the drug acting inside the body to “selectively and preferentially target cancer cells with therapeutic doses of TUSC2 in both primary and metastatic tumors,” according to a Genprex press release. The result in early tests showed tumor responses in primary and metastatic tumors alike. The current trial will seek to determine if Oncoprex plus erlotinib can continue to prove that it is a viable drug for treating late-stage lung cancers.