Tracking the Oncology Pipeline: Developments From ESMO

Published: Thursday, Oct 25, 2012

Hand picking up a test tubeThe latest research on several investigational cancer therapies was presented at the European Society for Medical Oncology (ESMO) 2012 Congress, which took place from September 28-October 2 in Vienna, Austria. Below is a highlight of several key presentations.

  • Ariad Pharmaceuticals reported initial data from its ongoing phase I/II clinical trial of its dual ALK/EGFR inhibitor AP26113, showing the drug had impressive antitumor activity in patients with ALK-positive non—small cell lung cancer (NSCLC), including patients with crizotinib resistance. Additionally, the tyrosine kinase inhibitor demonstrated initial evidence of antitumor activity in patients with EGFR-positive NSCLC, including patients with erlotinib resistance. (http://goo.gl/4pdS5)

  • Combination therapy with the BRAF inhibitor dabrafenib and the MEK inhibitor trametinib led to a 3.6-month progression-free survival benefit compared with dabrafenib alone in patients with BRAF V600 mutation—positive metastatic malignant melanoma, according to data from a phase II study. GlaxoSmithKline, which manufactures both drugs, has already launched a phase III trial of the combination therapy. The company submitted the drugs individually for FDA approval in August. (http://goo.gl/aNG7N)

  • An updated analysis of the phase III EMILIA trial showed that Genentech’s antibody-drug conjugate T-DM1 significantly extended overall survival by 5.8 months compared with the combination of lapatinib/capecitabine in patients with HER2-positive, unresectable, locally advanced or metastatic breast cancer. Genentech submitted the drug to the FDA for approval in August. (http://goo.gl/2GMKv)

  • Exelixis announced that in an ongoing nonrandomized expansion cohort of a phase II trial, a dose of 40 mg daily of cabozantinib had similar clinical activity as a dose of 100 mg daily in patients with heavily pretreated metastatic castration-resistant prostate cancer and bone metastases. The lower dose produced similar reductions in softtissue and metastatic bone disease, as well as substantial pain relief with a narcotic-sparing effect. The reduced dose also appeared to increase tolerability. Earlier phase II results had demonstrated positive results with the 100-mg daily dose; however, over 80% of patients required a dose reduction. Researchers are hoping to identify an optimal dose and move forward to a phase III trial. (http://goo.gl/V0Fk2)

  • Interim analysis data from the phase IIb/III GALAXY trial showed a trend toward an overall survival benefit with ganetespib, a small-molecule inhibitor of heat-shock protein 90, in patients with the adenocarcinoma type of non—small cell lung cancer (NSCLC). GALAXY is evaluating ganetespib plus docetaxel versus docetaxel alone in the second-line NSCLC setting. With secondary endpoints, the data demonstrated that the ganetespib group had improved progression-free survival (4.2 months vs 2.8 months) and overall response rate (16% vs 8%) versus the control arm. Synta Pharmaceuticals expects to complete GALAXY phase IIb patient enrollment and transition to phase III by year’s end. (http://goo.gl/5G1S7)

  • Threshold Pharmaceuticals reported updated phase IIb study results ahead of ESMO 2012 showing a nonsignificant 2.3-month median overall survival (OS) improvement with its investigational hypoxia-targeted drug TH-302 plus gemcitabine versus gemcitabine alone in patients with advanced pancreatic cancer. Results from the study presented in February had shown a statistically significant 2-month progression-free survival benefit with TH-302. At ESMO, study discussant Mitesh Borad, MD, Mayo Clinic, Scottsdale, Arizona, explained that the trial design had not been set up to detect a statistically significant OS improvement. He added that the OS data were complicated by the fact that patients in the control arm were allowed to cross over to the treatment arm at progression. Borad said a phase III trial is planned. (http://goo.gl/9YtlU)

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