September's top stories: Novartis Afinitor Phase III trial, Boehringer COPD study

Novartis reported positive Phase III trial results of pancreatic cancer drug Afinitor, Boehringer reported positive data from Phase III trials of COPD combination drug and Exelixis' Phase III prostate cancer trial of cabozantinib fails to meet primary endpoint. Drugdevelopment-technology.com wraps up key headlines from September 2014.


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Novartis reports positive Phase III trial results of pancreatic cancer drug Afinitor

Novartis reported final results from a Phase III trial of Afinitor (everolimus) tablets plus best supportive care (BSC) compared to placebo plus BSC in patients with well-differentiated advanced and progressive pancreatic neuroendocrine tumours (pNET).

The company noted that the RADIANT-3 trial met the secondary endpoint of overall survival.

Results from the trial showed a median OS of 44.02 months in the everolimus treatment arm and 37.68 months in the placebo arm, while the 6.34 month difference between the two arms was not statistically significant.

AstraZeneca's Phase III trial of diabetes drug exenatide meets primary endpoint

AstraZeneca reported positive results from its Phase III trial (DURATION-NEO-1) of exenatide to treat adult patients with type 2 diabetes.

The 28-week trial compared an investigational formulation of exenatide once-weekly suspension for autoinjection with twice-daily exenatide (Byetta) injection in these patients who had inadequate glycaemic control.

A total of 377 patients were enrolled in the randomised, open-label trial conducted across 59 centres.

The trial met its primary endpoint of non-inferiority, showing that exenatide once-weekly suspension for autoinjection provided greater mean reductions in HbA1c (blood glucose levels) compared to Byetta at 28 weeks.

Merck reports observational data of Januvia and metformin combination for type 2 diabetes

Merck reported data from an observational study that assessed the differences in initiated insulin therapy in patients with type 2 diabetes taking a combination of Januvia (sitagliptin) and metformin, as well as sulphonylurea and metformin.

The study found that patients administered with a combination of sitagliptin and metformin initiated insulin therapy at a slower rate than patients treated with sulphonylurea and metformin.

Under the study, initially 7,728 patients with type 2 diabetes were administered with sitagliptin or sulphonylurea as dual therapy with metformin for at least 90 days after starting sitagliptin or sulphonylurea in 2006 to 2013.

Boehringer reports positive results from Phase III trials of COPD combination drug

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Boehringer Ingelheim Pharmaceuticals reported data from the pivotal Phase III TONADO I and II trials (NCT01431274/NCT01431287) for the fixed-dose combination (FDC) of tiotropium, plus olodaterol to treat patients with moderate to very severe chronic obstructive pulmonary disease (COPD).

The once-daily tiotropium + olodaterol FDC is an investigational combination of the long-acting muscarinic antagonist (LAMA) tiotropium and olodaterol, a long-acting beta agonist (LABA) delivered via the Respimat inhaler.

More than 5,500 patients with COPD were involved in the 52-week double-blind, parallel-group TONADO trials.

Boehringer Ingelheim Pharmaceuticals Clinical Development and Medical Affairs senior vice-president Tunde Otulana said: "The TONADO results, together with the VIVACITO data presented at a major medical meeting earlier this year, formed the basis of the recent regulatory submission to the US Food & Drug Administration for tiotropium + olodaterol FDC delivered via the Respimat inhaler.

Exelixis' Phase III prostate cancer trial of cabozantinib fails to meet primary endpoint

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US-based biopharmaceutical firm Exelixis reported disappointing top-line results from the final analysis of COMET-1, the Phase III trial of cabozantinib in men with metastatic castration-resistant prostate cancer (mCRPC).

The trial evaluated cabozantinib in mCRPC patients whose disease progressed after treatment with docetaxel as well as abiraterone and/or enzalutamide.

The company said that the trial failed to meet its primary endpoint of showing a statistically significant increase in overall survival (OS) for patients treated with cabozantinib as compared to prednisone.

Abbvie's Phase III trial of Humira meets primary endpoint

AbbVie reported positive results from a Phase III pivotal trial, which was designed to evaluate the investigational use of Humira (adalimumab) in patients with moderate-to-severe hidradenitis suppurativa (HS).

The Phase III PIONEER I trial met its primary endpoint and also showed that Humira is effective in reducing common clinical signs and symptoms in moderate-to-severe HS, specifically the number of abscesses and inflammatory nodules.

Dermatologists refer HS as acne inversa, which is a chronic skin disease characterised by inflamed areas typically located around the armpits, groin, on the buttocks, and under the breasts.

Senesco completes patient enrolment in Phase Ib/IIa SNS01-T trial

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US-based biotech firm Senesco Technologies completed patient enrolment in its ongoing Phase Ib/IIa clinical trial of SNS01-T to treat patients with relapsed or refractory multiple myeloma, plasma cell leukemia or B cell lymphoma.

A first-in-class modulator of eukaryotic translation initiation factor 5A (eIF5A), SNS01-T is a new approach to cancer therapy that is designed to trigger apoptosis in B-cell cancers.

The safety portion of the open-label, multiple-dose, dose-escalation trial has established a maximum tolerated dose following the reporting of a second dose limiting toxicity (DLT) in the fourth and highest dosing group, which included a total of eight patients.

Celsion enrols first patient in Phase III liver cancer trial of ThermoDox

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US-based oncology drug development firm Celsion has enrolled the first patient in its pivotal Phase III OPTIMA trial of ThermoDox, a heat-activated, liposomal encapsulation of doxorubicin, to treat patients with primary liver cancer, also known as hepatocellular carcinoma (HCC).

South Korea's Kyungpook National University Hospital has conducted treatment for the first patient in the trial.

Around 550 patients at about 100 sites in the North America, Europe, China and Asia Pacific will be enrolled in trial.