Targeted failures of the week. Post No 75 - 81. Iniparib, Otamixaban, Alimta, Cetuximab, GemVax pancreatic cancer vaccine and Ganetespib

This week is a something regarding the amount of failed drug candidate. And almost all failures are "targeted" medicines:

 

Two phase 3 trials -- one for the cancer-fighting drug Iniparib and the other for Otamixaban, a therapy designed for use in treating coronary disease -- have been terminated due to a lack of results, Sanofi  announced today.

In the Iniparib study, newly diagnosed cell lung patients were treated with the drug in conjunction with chemotherapy. According to Sanofi, "There were no clinically meaningful differences in the main safety parameters," compared to patients who received chemotherapy alone. Ending development of Iniparib will result in a $235 million non-cash charge recognized on Sanofi's June 30, 2013 consolidated balance sheet.

The results for the anticoagulant Otamixaban were also unsuccessful and the drug did not "meet its primary endpoint of superiority over current therapy," according to Sanofi. Following the study, it was determined that the investigational program for Otamixaban will also be discontinued.

 

Drug maker Eli Lilly and Co. announced Monday that study of Alimta or pemetrexed for injection for treatment of non-squamous non-small cell lung cancer or NSCLC failed to achieve primary superiority endpoint.

According to the company, the Pronounce study did not achieve its primary superiority endpoint of improved progression-free survival without grade four adverse events or G4PFS. The safety and efficacy profile for Alimta has been the subject of Lilly-sponsored studies involving an estimated 32,500 patients over the span of about 20 years.

The study revealed no significant difference between the treatment arms for secondary endpoints of progression-free survival or PFS overall survival, overall response rate and disease control rate. Toxicity profiles observed were consistent with the known safety profiles of each therapy.

The Pronounce trial compared Alimta, carboplatin doublet regimen to a paclitaxel, carboplatin and bevacizumab triplet regimen.

Pronounce is a randomized, open-label Phase III superiority study of first-line chemotherapy pemetrexed plus carboplatin, followed by maintenance pemetrexed, compared to paclitaxel plus carboplatin plus bevacizumab, followed by maintenance bevacizumab in patients with advanced non-squamous NSCLC conducted in the U.S.

           

Merck KGaA said first-line treatment with Erbitux cetuximab plus FOLFIRI chemotherapy missed the primary endpoint of significantly improving objective response rate (ORR) ORR vs. Avastin bevacizumab plus FOLFIRI chemotherapy (62% vs. 58%, p=0.183) in the Phase III FIRE-3 trial to treat colorectal cancer. On secondary endpoints, median progression-free survival (PFS) was similar between the Erbitux and Avastin arms (10 vs. 10.3 months), but median overall survival (OS) was significantly improved in the Erbitux vs. Avastin arm (28.7 vs. 25 months, p=0.017). The University of Munich sponsored the open-label trial, which enrolled 592 patients with wild-type K-Ras colorectal cancer. Data were presented at the American Society of Clinical Oncology meeting in Chicago.

 

GemVax & Kael Co. Ltd.  said both concurrent and sequential administrations of GV1001 plus standard of care of gemcitabine and capecitabine missed the primary endpoint of improving overall survival (OS) vs. SOC alone in the Phase III TeloVac trial to treat non-resectable pancreatic cancer. The open-label, U.K. trial enrolled 1,062 patients with advanced and metastatic pancreatic cancer.

 

 

The efficacy of Synta Pharmaceuticals' lung cancer drug ganetespib is weakening over time, which should raise even more concerns about the ongoing phase III clinical trial.