Washington: Several new first-in-man studies for drugs targeted against a range of cancers have provided positive results.
The studies were released at the ESMO 2012 Congress of the European Society for Medical Oncology in Vienna.
“These studies represent our first glance at some of the drugs that may improve cancer treatment in coming years,” said Prof Ahmad Awada, head of the medical oncology clinic at Jules Bordet Institute, Brussels, Belgium, chair of the ESMO 2012 Developmental Therapeutics track.
“Today’s findings highlight the ways that clinical research is working on cancer therapies that target specific molecular pathways within tumor cells and their microenvironment. At ESMO 2012 this year, interesting early reports will be presented on MEK-, MET- and HSP90 inhibitors as well as studies on drugs targeting EGFR and PI3K and agents active in ALK-positive lung cancer resistant to crizotinib. In addition, new immunotherapeutic strategies and new generations of hormonal agents will be at the menu at this year’s ESMO congress,” he added.
Key selected studies include: A proof-of-concept study of ODM-201 in patients with progressive castration-resistant prostate cancer.
In a dose-escalation trial, 87 percent of 15 patients who received a novel androgen receptor agonist called ODM-201 experienced a PSA decrease at 12 weeks.
“These early results are very promising, and such are rarely seen in these early trials. ODM-201 might be a new hormonal treatment option, and its efficacy-safety profile seems to be very promising in prostate cancer patients,” said study author Dr Christophe Massard from Institute Gustave Roussy.
“Unlike other anti-androgens, according to non-clinical data, ODM-201 has minimal or no brain entrance, and thus no testosterone increase in animal models. Therefore ODM-201 could be a promising new drug option for patients with metastatic or non metastatic prostate cancer. The results need to be confirmed in bigger patient population of course,” Dr Massard added.
A dose-escalation study of oral selective c-Met inhibitor EMD 1214063 in patients with advanced solid tumors was also conducted.
The cell surface receptor tyrosine kinase c-Met is an emerging target for cancer treatment. EMD 1214063 is a highly selective, reversible and ATP-competitive c-Met inhibitor that causes growth inhibition and regression of HGF-dependent and HGF-independent tumors in pre-clinical models. This dose-escalation study is ongoing, with some preliminary evidence of clinical response being seen.
Another is the multicenter study of the investigational drug TAK-733, an oral MEK inhibitor.
Preliminary data of this trial in patients with advanced solid tumors indicate that TAK-733 is generally well tolerated and pharmacodynamically active with signs of anti-tumor activity in patients with advanced non-hematologic malignancies, said researchers.
Againp phase II study of HSP90 inhibitor AUY922 in patients with ALK-rearranged or EGFR-mutated advanced lung cancer showed positive results.
Among 121 patients with previously treated non-small cell lung cancer, activity was demonstrated in both ALK+ and EGFR-mutant patients, said investigators. Overall tumor response and progression-free survival rates observed warrant further studies, particularly among EGFR-mutant patients.
Results of a first-in-human study of the ALK inhibitor LDK378 in advanced solid tumors were also presented in the conference.
Investigators report striking activity in ALK+ non-small cell lung cancer patients treated at doses over 400mg who had previously progressed following crizotinib.
Scientists also reported findings of a dose-finding study of the ALK/EGFR inhibitor AP26113 in patients with advanced malignancies.
AP26113 was well tolerated with preliminary anti-cancer activity in ALK+ patients naive to, or failing, prior crizotinib, researchers said.