Product Development

Eiger’s Phase II ubenimex for lymphedema evokes mostly expert optimism based on earlier data, mechanism

Eiger BioPharmaceuticals’ (NASDAQ:EIGR) ubenimex for lymphedema triggered mostly optimistic expert expectations for the Phase II primary outcome. They pointed to positive clinical results of a molecule with a similar MOA and preclinical data with ubenimex that supports that mechanism.

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Pharma underutilises avenues to attract, retain trial patients; advocacy influence rising, delegates at Arena International say

Pharma can better attract patients to clinical trials through working with patient advocacy groups to generate feasible trial designs and offering to offset trial costs, said delegates at Arena International’s Outsourcing in Clinical Trials UK and Ireland 2018.

Speakers also touched on the need for trial recruitment and retention improvements, with a focus on the use of social media for recruitment and consistent communication between patients and trial sites -- during and after trials -- to ensure patient retention and continued involvement in future studies.

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Immunomedics’ sacituzumab has insufficient dataset to pursue accelerated approval despite impressive ORR in HR+ Her2-negative breast cancer, experts say

Immunomedics’ (NASDAQ:IMMU) Phase I/II sacituzumab govitecan hormone receptor positive (HR+) Her2-negative breast cancer data may not be enough for an accelerated approval despite showing clinically significant responses in a heavily pretreated population and a similar path adopted in triple-negative breast cancer (TNBC), experts said.

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Roche’s first-line NSCLC IMpower131 and IMpower150 Tecentriq studies struggle to find efficacy leverage over Merck’s Keytruda, experts say

Roche’s Tecentriq (atezolizumab) may have fallen behind Merck’s (NYSE:MRK) Keytruda (pembrolizumab) in the first-line non-small cell lung cancer (NSCLC) population following ASCO releases, experts said.

Heading into ASCO, analysts were looking to analyze full IMpower150 and IMpower131 data to understand the market scenario for Tecentriq versus Keytruda, especially considering the latter’s positive Keynote-189 data of Keytruda/paclitaxel with Eli Lilly’s Alimta (pemetrexed) in nonsquamous NSCLC, which was presented at AACR in April.

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Celgene’s Phase III Abraxane/gemcitabine needs to best adjuvant pancreatic cancer SOCs but efficacy success bar unclear

Celgene is testing Abraxane (nab-paclitaxel), which is approved to treat metastatic pancreatic cancer, as an adjuvant therapy in a late-stage trial, and will need to show superior overall survival (OS) data compared to what doctors currently use as standard of care.

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Shorter antibiotic courses have health benefits but more evidence needed before prescription overhaul

An investigator-sponsored clinical trial presented at the recent European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) conference in Madrid, Spain indicated a seven-day antibiotic course delivered similar outcomes to a 14-day course for Gram-negative bacteremia. Whilst there are health benefits to a shortened treatment, more studies are needed to change prescribing behaviors, experts noted.

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AstraZeneca’s failed Phase III COPD trials for Fasenra could indicate limited role in asthma-COPD overlap syndrome alone, experts say

AstraZeneca’s (LON:AZN) Fasenra (benralizumab) failures in chronic obstructive pulmonary disease (COPD) could be due to the antibody’s activity being limited to only those patients with an asthma-COPD overlap syndrome (ACOS) phenotype, where the drug’s use could be further explored, said experts.

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FDA’s gene therapy discussions stump industry experts on specifics of upcoming guidance for early scalable manufacturing; optimism perseveres on agency's tone

Gene therapy developers face intricate manufacturing scale-up challenges that will likely take years to resolve, despite the FDA’s intention to issue guidance on solidifying CMC commercial strategies at the IND stage, industry executives noted.

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Pfizer’s Xtandi approvable in nmCRPC followed by Bayer/Orion’s darolutamide; Xtandi, J&J’s Erleada’s familiarity casts uptake challenge for darolutamide, experts say

Pfizer’s (NYSE:PFE) Xtandi (enzalutamide) is likely to receive an expanded label approval in nonmetastatic castration-resistant prostate cancer (nmCRPC) due to strong Phase III data and its well-understood MOA, experts said. Phase III metastatic-free survival (MFS) success was similar to Johnson & Johnson’s (NYSE:JNJ) already approved Erleada (apalutamide), prompting confidence for Pfizer’s nonsteroidal antiandrogen (NSAA) to enter the market for first-line competition, they noted.

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Progenics' Azedra FDA approval in rare neuroendocrine tumours supported by hypertension data but lack of PFS data could be a spoiler, experts say

(NASDAQ:PGNX) Azedra (Ultratrace I-131-MIBG) FDA approval for pheochromocytoma (pheo) and paraganglioma (para) is supported by encouraging Phase IIb data showing its ability to reduce antihypertensive medication use, experts said. However, they were divided if the trial should have also included a progression-free survival (PFS) co-primary endpoint for a more convincing FDA win.

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