Product Development

Reata Pharmaceuticals’ (NASDAQ:RETA) Phase II trial of RTA408 (omaveloxolone) in primary mitochondrial myopathy (MM) has triggered expert efficacy optimism based on the drug’s Phase II success in the related indication Friedreich’s ataxia (FA). Experts differed in their certainty of RTA408 achieving clinically significant efficacy and disagreed on the threshold of clinical benefit in MM.

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By: Alaric DeArment in New York and Fiona Barry in London

Ra Pharmaceuticals’ (NASDAQ:RARX) potential Phase III trial of C5 inhibitor RA101495 in paroxysmal nocturnal hemoglobinuria (PNH) patients should have a switching design in patients demonstrating suboptimal response to the standard order of care (SOC) to overcome patient recruitment difficulties, experts said.

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AstraZeneca’s (LON:AZN) Tagrisso (osimertinib) Phase III data in first-line EGFR mutant non-small-cell lung cancer (NSCLC) has oncologists noting it will likely be the new standard of care (SOC) due to its similar efficacy to comparators as well as CNS metastases activity and tolerability benefits. However, some oncologists noted that some key questions on whether a greater progression-free survival (PFS) benefit could be obtained through sequencing agents have not been answered by the Phase III FLAURA trial design.

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Pfizer (NYSE:PFE) and Merck KGaA’s (ETR:MRK) Phase III first-line advanced renal cell carcinoma (RCC) JAVELIN 101 study of PD-L1 inhibitor Bavencio (avelumab) in combination with Pfizer’s Inlyta (axitinib) met its initial recruitment target of 583 patients in summer 2017, said a source familiar with the trial.

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AstraZeneca’s (LON:AZN) PACIFIC Phase III of Imfinzi (durvalumab) results in unresectable Stage III non-small-cell lung cancer (NSCLC) following concurrent chemoradiotherapy will trigger immediate practice changes, oncologists said. They added the results should likely lead to regulatory approvals, despite the full overall survival (OS) data not yet being available.

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Artificial intelligence/machine learning (AI/ML) advances that allow clinical trial sponsors to create synthetic control arms (SCAs) -- instead of enrolling patients on active comparators – are expected to provide better quality data for drug development “go”/“no-go” decisions, experts said. SCAs will also allow sponsors to generate investor confidence in early-phase assets, they said.

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Roche’s (VTX:ROG) Tencentriq (atezolizumab)/chemotherapy combination arm in the Phase III IMpower150 first-line non-small-cell lung (NSCLC) trial faces a difficult challenge to show a significant benefit over Avastin (bevacizumab)/chemotherapy, oncologists said.

This news service reported on 23 August the triplet combination of Tecentriq/Avastin/chemotherapy is likely to be successful. Analysts have largely commented on the success potential of the triplet combination rather than the doublet.

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Global Blood Therapeutics’ (NASDAQ:GBT) GBT440 has a mixed Phase II outlook in idiopathic pulmonary fibrosis (IPF) patients due to challenges in recording accurate improvements in oxygen saturation and clinical translation of such changes, expert said.

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By Reynald Castaneda in London

Resverlogix's (TSE:RVX) apabetalone for reducing cardiovascular disease (CVD) event risk has experts debating whether its targeting of diabetic patients with impaired kidney function could backfire in a Phase III trial, reducing its approval prospects. One expert noted this is a difficult population to study, however others added the company has some post-hoc data supporting usage in these patients.

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AstraZeneca’s (LON:AZN) Phase III study of Tagrisso (osimertinib) requires at least a 22-month progression-free survival (PFS) in order to be clinically viable in first-line EGFR mutant non-small-cell lung cancer (NSCLC), experts said.

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