June’s top news stories

5th July 2018 (Last Updated July 5th, 2018 00:00)

Servier and Galapagos commenced the ROCCELLA Phase 2 clinical trial to evaluate the efficacy and safety of S201086/GLPG1972 to treat patients with knee osteoarthritis (OA); and Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company reported positive top-line results from the EASE trial programme. Drugdevelopment-technology.com wraps up the key news stories from June 2018.

Servier and Galapagos began ROCCELLA trial

Servier and Galapagos commenced the ROCCELLA Phase 2 clinical trial to evaluate the efficacy and safety of S201086/GLPG1972 to treat patients with knee osteoarthritis (OA).

The multi-regional, randomised, double-blind, placebo-controlled, dose-ranging trial expects to enrol around 850 patients in up to 15 countries worldwide.

As part of the trial, three different once-daily doses of S201086/GLPG1972 will be given to the patients.


Boehringer Ingelheim reported positive top-line results from EASE trial

Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company reported positive top-line results from the EASE trial programme, which includes two Phase III studies designed to examine empagliflozin in combination with insulin therapy in adults with type 1 diabetes.

The multinational, double-blinded, placebo-controlled trials investigated the efficacy, safety and tolerability of once-daily empagliflozin as adjunctive to insulin therapy in the enrolled patients.

As part of the EASE-2 trial, 10mg and 25mg doses of empagliflozin were evaluated as adjunct to insulin versus placebo for 52 weeks.


Blueprint dosed first patient in Voyager trial

Blueprint Medicines dosed the first patient in the Voyager trial, a Phase III clinical study investigating the safety and efficacy of avapritinib in comparison with regorafenib to treat patients with advanced gastrointestinal stromal tumours (GIST).

Around 460 patients previously treated with imatinib and one or two additional tyrosine kinase inhibitors (TKIs) will be enrolled in the global, open-label randomised trial.

Patients across the US, Europe, Australia and Asia will be randomised in a 1:1 ratio to receive avapritinib 300mg once daily (QD) or regorafenib 160mg QD for three weeks, followed by one week off.


Novartis reported positive interim data from OLE trials of Aimovig

Novartis reported positive results from an interim analysis of two open-label extension studies (OLE) of Aimovig (erenumab) for the treatment of patients with chronic and episodic migraine.

The new findings have supported the established safety and efficacy profile of Aimovig in long-term use for patients with chronic migraine, as well as demonstrated the long-term safety and tolerability of Aimovig in episodic migraine.

The OLE in chronic migraine trial enrolled 609 patients who completed a Phase II, 12-week, double-blind, placebo-controlled parent trial.


NIH initiated trial to assess vaccine against respiratory syncytial virus

US NIH division the National Institute of Allergy and Infectious Diseases (NIAID) initiated a Phase I clinical trial to evaluate an investigational intranasal vaccine called SeVRSV to protect from respiratory syncytial virus (RSV).

SeVRSV consists of a modified mouse virus (Sendai virus) that carries RSV genetic material intended to express RSV fusion protein in the recipient in order to trigger RSV-specific antibodies and T-cells.

According to the NIH, the Sendai virus vaccine platform demonstrated favourable tolerability profile in human clinical trials of other infectious disease vaccines such as HIV treatments.


Roche reported positive results from CLL11 study of obinutuzumab

Roche reported positive results from the final analysis of the phase III study CLL11 assessing Gazyva/Gazyvaro (obinutuzumab)-based treatment in previously untreated chronic lymphocytic leukaemia (CLL).

The multi-centre, open-label, randomised three-arm investigated the safety and efficacy profile of Gazyva/Gazyvaro plus chlorambucil in comparison with MabThera/Rituxan plus chlorambucil or chlorambucil alone in nearly 800 people with previously untreated CLL and comorbidities.

The study’s primary endpoint is progression-free survival (PFS) and secondary endpoint included response rate, molecular remission rate, overall survival (OS), TTNT and safety profile.


Ironwood began two Phase III trials of IW-3718

Ironwood Pharmaceuticals commenced two Phase III clinical trials to examine the safety and efficacy of IW-3718 in patients with persistent gastroesophageal reflux disease (GERD).

Both the randomised, double-blind, placebo-controlled, multicentre trials aim to enrol a total of around 1,320 patients with persistent GERD who demonstrate evidence of pathological acid reflux.

Patients will be equally distributed in the trials and will continue to take proton pump inhibitors (PPIs).


Pfizer unveiled new results from PALOMA-3 trial for breast cancer

Pfizer revealed new data from the PALOMA-3 trial, a Phase lll study that evaluated Ibrance (palbociclib) in combination with fulvestrant compared to placebo plus fulvestrant for the treatment of women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer.

The trial enrolled HR+/HER2- metastatic breast cancer patients whose disease progressed after prior endocrine therapy.

Results of the trial showed that a positive trend in the overall survival in certain patients, which is the secondary goal, but this trend did not reach statistical significance.


Genentech reported positive outcome from IMpower133 study

Genentech reported positive results from the IMpower133 study after the trial met its co-primary endpoints of overall survival (OS) and progression-free survival (PFS) at the first interim analysis.

IMpower133 is a Phase III, multicentre, double-blinded, randomised placebo-controlled trial designed to investigate the efficacy and safety of Tecentriq (atezolizumab) in combination with carboplatin and etoposide versus chemotherapy (carboplatin plus etoposide) alone in chemotherapy-naïve patients with extensive-stage small cell lung cancer (ES-SCLC).

The trial enrolled 403 patients randomised equally in a 1:1 ratio to receive Tecentriq in combination with carboplatin and etoposide, or a placebo in combination with carboplatin and etoposide.


AstraZeneca and Merck reported positive data from SOLO-1 trial

AstraZeneca and Merck reported positive results from the Phase III SOLO-1 trial of Lynparza (olaparib) for the treatment of BRCA-mutated (BRCAm) ovarian cancer.

The randomised, double-blinded, placebo-controlled, multicentre trial was designed to analyse the efficacy and safety of Lynparza as the first-line maintenance monotherapy compared with placebo in the enrolled patients.

As part of the study, 391 patients with a deleterious or suspected deleterious BRCA1 or BRCA2 mutation who were in clinical complete or partial response following platinum-based chemotherapy were randomised at a 2:1 ratio to receive 300mg of Lynparza or placebo twice daily.