Product Development

Multiple reported patient deaths through the FDA reporting system for patients taking Roche’s (VTX:ROG) Ocrevus (ocrelizumab) for multiple sclerosis has led to the company launching an investigation into the cases, said a source familiar with the situation. Two additional sources familiar with the drug said they also heard about the deaths, adding a number of questions regarding the nature of the cases remain unanswered.

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GlaxoSmithKline’s (LON:GSK)/ViiV Healthcare’s Phase III Tivicay (dolutegravir)/ Epivir (lamivudine) combination for HIV treatment-naïve patients versus triple therapy has experts unsure about its success, due to the comparator’s high bar and uncertainty associated with doublets when a triple has been approved.

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Asterias Biotherapeutics’ (NYSEAMERICAN:AST) AST-OPC1 initial cohort data from its Phase I/IIa study has experts cautiously excited for its potential to treat spinal cord injury in this and additional cohorts. Given the uncontrolled trial design, efficacy possibility can be hedged, they said; however, the data was strong enough to convince them of a real effect size.

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BeiGene’s (NASDAQ:BGNE) Phase III study comparing BGB-3111 against AbbVie (NYSE:ABBV)/Johnson & Johnson's (NYSE:JNJ) Imbruvica (ibrutinib) in Waldenström’s macroglobulinemia (WM) has enrolled 53 patients out of 167 as of 3 October with CRO Parexel (NASDAQ:PRXL), said a source briefed on the trial.

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Fortress Biotech’s (NASDAQ:FBIO) Phase II trials of CEVA101 are likely to see similar meaningful decreases in brain matter volume loss following traumatic brain injury (TBI) as observed in Phase I, experts said. Phase II's imaging-related endpoint is not necessarily a conventional TBI endpoint but is indeed clinically meaningful and is expected to correlate with global functional outcomes, they added.

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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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