Clinical Catch-Up for June 17-21

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Plenty of biopharma companies released results from clinical trials last week. Here’s a look at the top stories.

VBI Vaccines announced positive top-line data from its Phase III PROTECT trial comparing its Sci-B-Vac trivalent hepatitis B vaccine to GlaxoSmithKline’s Engerix-B vaccine. The trial found that Sci-B-Vac was non-inferior to Engerix-B, two of its primary endpoints. Those endpoints were non-inferiority in all adults 18 years of age and older and superiority in adults 45 years of age or older. However, the trial did not meet the secondary endpoint, non-inferiority in two doses of Sci-B-Vac at day 168 compared with three doses of Engerix-B at day 196.

Calithera Biosciences released positive results from its Phase III ENTRATA trial of telaglenastat in combination with everolimus in advanced renal cell carcinoma (RCC). The combo doubled the median progression-free survival (PFS) in heavily pre-treated patients with advanced RCC. The patients in the trial had received a median of three previous lines of therapy including 70% with two or more previous tyrosine kinase inhibitors (TKI) and 68% with intermediate/poor MSKCC prognostic score. 88% had received previous PD-1/PD-L1 therapy. The median PFS went from 1.9 months for everolimus alone to 3.8 months with the combination, decreasing the risk of disease progression or death by 36%.

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Adamas Pharmaceuticals performed a retrospective data analysis from pooled Phase III trials of Gocovri (amantadine) in Parkinson’s disease. The drug, which has been approved by the FDA for the treatment of dyskinesia in Parkinson’s patients receiving levodopa-based therapy, showed a reduction in the number, duration and transitions between episodes of dyskinesia and OFF periods experienced daily by patients.

“This retrospective data analysis provides a window into the true patterns of these episodes throughout the day and how Gocovri can reduce both the number and duration of these episodes of troublesome dyskinesia and OFF, consistent with the data from Gocovri’s Phase III clinical studies,” stated Robert A. Hauser, Professor of Neurology and Director, USF Health Byrd Parkinson’s Disease and Movement Disorders Center Parkinson Foundation Center of Excellence.

Ironwood Pharmaceuticals and Allergan announced positive topline data from their Phase IIIb clinical trial of Linzess (linaclotide) in irritable bowel syndrome. The drug is marketed by both companies in the U.S. for adults with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC). In this trial, the drug was being evaluated for improvement in the overall abdominal symptoms, bloating, pain and discomfort, that adult IBS-C patients experience. The trial compared the drug to placebo.

The trial also met both secondary endpoints. The drug showed a statistically significant and clinically meaningful improvement in overall abdominal symptoms compared to placebo for all primary and secondary endpoints.

BeiGene updated results from two ongoing clinical trials of its BTK inhibitor zanubrutinib in patients with mantle cell lymphoma (MCL). The first was in a Phase II trial of the drug as a monotherapy in relapsed/refractory MCL being conducted in China. Eighty-six patients were enrolled who had a median of two (1 to 4) previous lines of therapy. As of a February 15 cutoff data, 60.5% of patients remained on treatment, ORR was 83.7%, complete response (CRO) was 77.9% and partial response (PR) was 5.8%.

The second trial is a Phase I/II trial of the drug as a monotherapy in B-cell malignancies, including MCL, being run in the U.S., Australia, Italy, South Korean, New Zealand, and the UK. As of December 13, 2018, 53 patients with treatment native MCL were enrolled, 48 were evaluable for efficacy with a median follow-up time of 16.7 months. For the group, the ORR was 85.4%, the CR rate was 29.2% and the PR rate was 56.3%.

Ritter Pharmaceuticals provided an updated on its Phase III clinical trial of RP-G28, Liberatus, for lactose intolerance. The treatment is a therapeutic to modulate the gut microbiome. The trial, the company says, is on schedule with an anticipated top-line data readout early in this year’s fourth quarter. The company has also had meetings with the FDA to confirm the analyses as defined in their Statistical Analysis Plan (SAP) would be supported by the agency.

Horizon Therapeutics initiated a clinical trial of Krystexxa (pegloticase injection) with methotrexate for gout refractory to conventional therapies. In the trial, 135 adults will be randomized to receive methotrexate or placebo for four weeks, then receive Krystexxa and methotrexate or Krystexxa and placebo for 52 weeks. The primary endpoint will be measured at Month 6 with a six-month follow-up.

Exelixis’ combination of Cotellic (cobimetinib) and Genentech’s Tecentriq (atezolizumab) failed to hit a Phase III trial endpoint in melanoma. The endpoint was progression-free survival (PFS). The IMspire170 trial was studying the combination in comparison to Merck’s Keytruda (pembrolizumab) in patients with previously untreated BRAF V600 wild-type advanced melanoma.

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