Unum plans additional cohort after cytokine release syndrome, neurotoxicity reports in Phase I lymphoma cell therapy study – source
Cytokine release syndrome (CRS) and neurotoxicity incidents have prompted Unum Therapeutics to evaluate a new dosing cohort in its Phase I study of cell therapy ACTR087 in relapsed/refractory non-Hodgkin’s lymphoma, said a source briefed on the situation.
Seres’ SER-287 elicits overall uncertainty for microbiome change for ulcerative colitis, maintenance use a possible prospect but with caveats – experts
Seres Therapeutics’ (NASDAQ:MCRB) Phase Ib SER-287 has drawn overall skeptical reviews from experts about its potential to change the microbiome of mild-to-moderate ulcerative colitis (UC) patients for clinical benefit. But any signal of microbial change in the trial’s patients would be welcome to help confirm SER-287 mechanism, they added.
Roche’s (VTX:ROG) Ocrevus (ocrelizumab) having additional reported cases of progressive multifocal leukoencephalopathy (PML) has not raised neurologist alarms despite analyst concern. Most physicians, familiar with treating PML, said the events should not negatively affect the medication’s uptake in multiple sclerosis (MS), despite contrary market opinions.
Biogen’s (NASDAQ:BIIB) recently announced Phase II trial design for opicinumab in relapsing remitting multiple sclerosis (RRMS) has experts optimistic that patient inclusion criteria could allow a positive trial outcome. That said, the company’s decision to allow any disease-modifying therapy (DMT) in the trial had some experts noting overall data analysis would be challenging.
Some experts also noted lingering doubts on positive results considering previous mixed trial results and the drug’s uncertain mechanism of action.
Advanced Accelerator Applications’ (NASDAQ:AAAP) Lutathera (177Lu-DOTATATE) for gastroenteropancreatic neuroendocrine tumours (GEP-NET) could face further FDA approval delays if concerns about its safety profile persist due to its radiolabeled molecule, experts said. However, they were overall optimistic Lutathera would be eventually approved due to its encouraging efficacy data.
Kala Pharmaceuticals’ (NASDAQ:KALA) KPI-121 (loteprednol etabonate) for acute symptoms of dry eye will have difficulty achieving its Phase III co-primary endpoint of significant ocular discomfort reduction as the drug demonstrated a failure in Phase II, said experts.
The trial design between Phase II and Phase III are very similar, with the only discernable difference being duration, and could see a replication in the failure. However, they added, the other co-primary endpoint of bulbar conjunctival hyperemia reduction has a good chance of repeating Phase II success.
Merck KGaA (ETR:MRK) has offered to pay for any additional disease-modifying therapies that multiple sclerosis (MS) patients may require during Mavenclad (cladribine) therapy, as part of ongoing reimbursement discussions with the UK’s National Institute for Health and Care Excellence (NICE), according to two sources familiar with the situation.
Gilead Sciences’ (NASDAQ:GILD) early ASH 2017 abstract data from the Phase I/II ZUMA-6 study of Yescarta (axicabtagene ciloleucel)/Roche’s (VTX:ROG) Tecentriq (atezolizumab) in diffuse large B-cell lymphoma (DLBCL) drew concerns from experts about high toxicity rates, albeit with the caveat of the data’s earliness and small patient numbers.
AstraZeneca’s (LON:AZN) benralizumab will likely have a dosing advantage over competitors in severe eosinophilic asthma, but may struggle to reach optimal market expectations, experts said. Convincing some physicians that it offers a superior efficacy profile for the majority of patients will be the major challenge, experts said.
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.