Product Development

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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Gilead’s filgotinib may pass Phase III risk-benefit bar in RA with JAK-1 target despite safety caution; efficacy has more assurances, experts say

(NASDAQ:GILD) GLPG0634 (filgotinib) for rheumatoid arthritis (RA) may see its more targeted mechanism offer safety advantages for its Phase III FINCH 2 trial, though reservations linger after Eli Lilly’s (NYSE:LLY) Olumiant (baricitinib) setbacks, experts said. They remain upbeat on the janus kinase 1 (JAK1) inhibitor’s potential to provide strong efficacy based on previous signals and comparisons to Pfizer’s (NYSE:PFE) approved drug in the same class, Xeljanz (tofacitinib).

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Lilly’s Trulicity CVOT has experts optimistic based on past results but hesitant since not all prior GLP-1 CVOTs have shown benefit

Eli Lilly’s (NYSE:LLY) Trulicity (dulaglutide) for type 2 diabetes (T2D) has three experts cautiously optimistic over its potential to show benefit in its cardiovascular outcome trial (CVOT) while one declined to note expectations. Experts agreed that uncertainty prevails given the variation in past CVOT results for similar agents and the lack of clarity over the MOA for CV benefit.

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Novartis’s Phase III Kisqali MONALEESA-3 study will likely continue establishing efficacy, 1L randomized Faslodex combo data could provide a small but distinct advantage, experts say

Novartis’ (VTX:NOVN) Phase III MONALEESA-3 trial is rational in combining Kisqali (ribociclib) with AstraZeneca’s (LON:AZN) Faslodex (fulvestrant) in first- and second-line HR+Her2-negative advanced metastatic breast cancer due to Faslodex’s efficacy advantage over aromatase inhibitors (AIs) that are commonly used in first-line disease, experts said. They added the trial is expected to be a positive study.

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HBV functional cure likely to be triple combo, but no clear backbone; capsid target too crowded with other approaches showing potential, experts say

A hepatitis B virus (HBV) functional cure will likely be a triple therapy combination for most patients, but it is unclear which of the current investigated therapies are likely to have a pivotal backbone role, experts said.

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Alexion’s Soliris for neuromyelitis optica treads fine line for Phase III safety; common side effects of low concern, experts say

Alexion Pharmaceuticals' (NASDAQ:ALXN) Soliris (eculizumab) is under close scrutiny for meningococcal infection risk in its Phase III for neuromyelitis optica (NMO), experts said. Even a low incidence of meningococcal infection is going to impact its risk profile, they said, though noted other adverse events (AEs) seem acceptable.

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Jounce’s JTX-2011 has promising mechanism but experts highlight earliness of evidence to back clinical efficacy; combination elicits higher efficacy potential

Jounce Therapeutics’ (NASDAQ:JNCE) JTX-2011 mechanism as an inducible T-cell co-stimulator (ICOS) agonist holds promise to spur immune responses in gastric and breast cancer, experts said. However, the absence of validated clinical data draws pause on forecasting Phase I/II trial success, they noted.

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