January's top stories: Bristol-Myers stops Opdivo trial, Boehringer COPD study

Bristol-Myers Squibb (BMS) stopped its open-label, randomised Phase III trial (CheckMate -017) evaluating Opdivo versus docetaxel, Boehringer started patient enrolment in its Dynagito study to treat COPD, while Medivation and Astellas report positive results from Phase II TERRAIN trial for prostate cancer. Drugdevelopment-technology.com wraps-up key headlines from January.


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Bristol-Myers' Phase III lung cancer trial of Opdivo stopped early

opdivo

Bristol-Myers Squibb (BMS) stopped its open-label, randomised Phase III trial (CheckMate -017) evaluating Opdivo versus docetaxel in previously treated patients with advanced, squamous cell non-small cell lung cancer (NSCLC).

CheckMate -017 was stopped early due to an evaluation conducted by the independent Data Monitoring Committee (DMC), which concluded that the trial met its endpoint, showing superior overall survival in patients receiving Opdivo compared to the control arm.

A total of 272 patients were enrolled in the trial and were given either nivolumab 3mg/kg intravenously every two weeks or docetaxel 75mg/m² intravenously every three weeks.

The trial's primary endpoint is overall survival, while secondary endpoints include objective response rate and progression free survival.

Boehringer begins patient enrolment in Dynagito study to treat COPD

Boehringer Ingelheim started patient enrolment in its large-scale Dynagito study to treat chronic obstructive pulmonary disease (COPD).

The trial is designed to evaluate the potential benefit of tiotropium + olodaterol Respimat FDC compared to Spiriva (tiotropium) Respimat on reducing the risk of sudden worsening of symptoms (exacerbations) and improving survival in these patients.

Around 7,800 patients in 59 countries will be enrolled in the 52-week multi-national double-blind trial.

The trial will investigate the impact of once daily, orally inhaled tiotropium + olodaterol Respimat FDC (5/5µg) compared to Spiriva Respimat monotherapy (5µg) on exacerbations in patients with severe to very severe COPD.

Medivation and Astellas report positive results from Phase II TERRAIN trial

prostate cancer

Medivation and Astellas Pharma reported positive topline results from the Phase II TERRAIN trial comparing enzalutamide with bicalutamide in men with metastatic castration-resistant prostate cancer.

The Phase II TERRAIN trial was designed to evaluate enzalutamide at a dose of 160mg taken once-daily versus bicalutamide at a dose of 50mg taken once-daily, the approved dose in combination with a LHRH analogue.

The trial achieved its primary endpoint showing a statistically significant increase in progression-free survival (PFS) for enzalutamide compared to bicalutamide.

Novartis reports positive Phase III trial results of Jakavi in PV patients

Novartis reported positive results from its pivotal Phase III clinical trial of Jakavi (ruxolitinib), an oral inhibitor of the JAK 1 and JAK 2 tyrosine kinases, for the treatment of patients with polycythemia vera (PV).

During the trial, a total of 222 patients with PV resistant to or intolerant of hydroxyurea were randomised 1:1 to receive either ruxolitinib (starting dose of 10mg twice daily) or standard therapy, which was defined as investigator-selected monotherapy or observation only.

The results showed that Jakavi improved hematocrit control without the need for phlebotomy and reduced spleen size in PV patients who had an inadequate response to or unacceptable side effects from hydroxyurea as defined according to the modified European LeukemiaNet (ELN) criteria.

ImmuPharma and Simbec-Orion to execute Phase III trial of Lupuzor to treat Lupus

UK-based companies ImmuPharma and Simbec-Orion Group entered a collaboration agreement to execute ImmuPharma's pivotal Phase III clinical trial of its lead compound Lupuzor to treat Lupus, a chronic, potentially life-threatening autoimmune disease.

Lupuzor (also called as Rigerimod, IPP-201101 and P140) has secured fast-track designation from the US Food and Drug Administration (FDA) as well as approval to initiate Phase III trials under a Special Protocol Assessment (SPA) due to its strong safety and efficacy profile.

The multi-centre Phase III trial will start immediately and will enrol patients across Europe, the US and other regions.

Seattle Genetics, BMS to evaluate Adcetris and Opdivo combination

lymphoma

Seattle Genetics and Bristol-Myers Squibb (BMS) entered a clinical trial collaboration agreement to evaluate the investigational combination of Adcetris and Opdivo in two planned Phase I/II clinical trials.

Adcetris (brentuximab vedotin) is Seattle Genetics' antibody-drug conjugate (ADC) and Opdivo (nivolumab) is BMS' human programmed death receptor-1 (PD-1) blocking antibody.

The first trial is designed to evaluate this combination as a potential treatment option for patients with relapsed or refractory Hodgkin lymphoma (HL). The second trial will focus on patients with relapsed or refractory B-cell and T-cell non-Hodgkin lymphomas (NHL), including diffuse large B-cell lymphoma (DLBCL).

The two trials are scheduled to be initiated in 2015, with Seattle Genetics conducting the HL trial and BMS conducting the NHL trial.

OncoMed begins patient enrolment in Anti-Notch1 Phase Ia trial to treat solid tumours

US-based OncoMed Pharmaceuticals enrolled first biomarker-selected patient in its Phase Ia solid tumour clinical trial of an anti-Notch1 antibody (OMP-52M51) to treat solid tumours.

Advancement to the predictive biomarker expansion stage triggered a $5m milestone from the company's partner GlaxoSmithKline (GSK).

The company said that patients tumours are pre-screened using its immunohistochemistry (IHC) test to determine eligibility.

They will receive anti-Notch1 at the recommended Phase II dose of 1.5mg/kg every three weeks.

Advaxis and GOG Foundation to partner on Phase III cervical cancer trial of ADXS-HPV

cervix

Advaxis is entering a clinical trial collaboration agreement with the Gynecologic Oncology Group (GOG) Foundation to evaluate safety and efficacy of the company's lead cancer immunotherapy ADXS-HPV in a global Phase III trial to treat cervical cancer.

ADXS-HPV is an investigational Lm-LLO immunotherapy designed to generate an immune response to the HPV-associated tumour specific oncogene.

Both parties will conduct an adequate and well-controlled Phase III clinical trial of concurrent chemotherapy and radiation therapy (CCRT) compared to CCRT combined with ADXS-HPV in women diagnosed with high-risk, locally advanced cervical cancer.