Product Development

Allena’s ALLN-177 in enteric or primary hyperoxaluria, hyperoxaluria culls physician doubt on Phase II endpoint though Phase III has higher hopes

Allena Pharmaceuticals’ (NASDAQ:ALNA) Phase II primary endpoint for ALLN-177 (oxalate decarboxylase) in enteric or primary hyperoxaluria and hyperoxaluria has experts noting likely plasma oxalate changes but are skeptical on the extent of potential clinical differences. Despite the skepticism, the drug may be useful as an adjuvant to other therapies for reducing plasma oxalate in patients with poor renal function, they said.

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AstraZeneca’s Imfinzi/tremelimumab will struggle to sit at first-line NSCLC table; Merck’s dominance, BMS’ niche biomarker offering generate preference, experts say

AstraZeneca (LON:AZN) is unlikely to find a distinct spot for Imfinzi (durvalumab) combined with tremelimumab in the highly coveted first-line (1L) non-small-cell lung cancer (NSCLC) space due to competition with immunotherapy(IO) combinations with chemotherapy and a lack of biomarker or toxicity advantages over other IO-only combinations, said experts.

Merck’s (NYSE:MRK) Keytruda (pembrolizumab) is the frontrunner, with an estimated 80% market share in the 1L NSCLC space and NSCLC revenues potentially reaching USD 8.5bn by 2022.

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UCB’s Phase III for bimekizumab should best AbbVie’s Humira, placebo in psoriasis, experts say; debate on next development steps

UCB’s (EBR:UCB) bimekizumab is expected to demonstrate a high bar of superiority to AbbVie’s (NYSE:ABBV) Humira (adalimumab) and placebo in its Phase III chronic plaque psoriasis study, experts said. Two noted they expected more than 90% of bimekizumab patients to hit the PASI90 primary endpoint.

Although analysts said bimekizumab’s mechanism of blocking both IL-17a and IL-17f compared to just IL-17a alone should demonstrate efficacy, two experts had concerns over the potential increase in adverse effects by targeting more than one cytokine.

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CMS’ Medicare Advantage step edits in Part B likely to have muted impact on biosimilar uptake due to influence of similar challenges with commercial plans, experts say

Increased autonomy awarded to Medicare Advantage (MA) plans by the Centers for Medicare and Medicaid Services (CMS) to introduce step edits for Part B therapies is unlikely to have a major impact on biosimilar uptake due to similar financial challenges as seen with commercial payers, said experts.

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Karyopharm’s interim Phase IIb selinexor data in later-line DLBLC draws reserved expert interest for full results, but durable response would stimulate enthusiasm

Karyopharm Therapeutics’ (NASDAQ:KPTI) Phase IIb SADAL trial investigating selinexor in refractory or relapsed (r/r) diffuse large B-cell lymphoma (DLBCL) draws cautious expert optimism for delivering clinically significant full results.

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Coherus BioScience’s Udenyca and CH-1420 biosimilars for Amgen’s Neulasta and AbbVie’s Humira have market uptake concerns despite likely approvals, experts say

Coherus BioSciences’ (NASDAQ:CHRS) biosimilars Udenyca, formerly known as CHS-1701 (pegfilgrastim), and CH-1420 (adalimumab) have US uptake concerns despite likely FDA approval expectations, experts said.

Despite analysts’ expectations that market penetration will happen at the expense of respective originator products, Amgen’s (NASDAQ:AMGEN) Neulasta (pegfilgrastim) and AbbVie’s (NYSE:ABBV) Humira (adalimumab), due to low biosimilar price tags, experts are more sceptical.

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Allergan’s abicipar generates reports of SAE hemorrhagic vasculitis in neovascular AMD Phase III program, investigators say

Allergan’s (NYSE:AGN) abicipar pegol may have cases of hemorrhagic vasculitis in its pivotal Phase III studies CEDAR and SEQUIOA in neovascular age-related macular degeneration (AMD), said three trial investigators.

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Inventiva’s addition of PPAR gamma to lanifibranor’s targets has unclear value in NASH, triggering uncertainty over Phase II success, experts say

Inventiva Pharma’s (EPA:IVA) lanifibranor has drawn expert reservations for Phase IIb NATIVE trial success in nonalcoholic steatohepatitis (NASH). Although adding PPAR gamma as a target is an attractive hypothesis, preclinical evidence of PPAR gamma’s value in NASH is foggy, they explained. Real-world experience with PPAR gamma therapies in diabetes, on the other hand, triggered mixed reviews on NASH relevance.

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Pfizer/Eli Lilly’s long-term Phase III for tanezumab in osteoarthritis still draws RPOA caution despite amendments and positive data, experts say

Pfizer (NYSE:PFE)/Eli Lilly’s (NYSE:LLY) tanezumab for osteoarthritis (OA) of the hip and knee may face hurdles to clear long-term efficacy and safety benchmarks, experts said.

While positive Phase III (NCT02697773) data announced on 18 July is encouraging, prior safety signals from tanezumab’s Phase II proof-of-concept trial (NCT00394563) – released in 2009 – has experts still cautious of incidences of rapidly progressive osteoarthritis (RPOA).

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Akcea's AKCEA-APO(a)-LRx needs Phase III Lp(a) measurements, CV risk specifics before CVOT initiation; positive Phase IIb trial expectations, experts say

Akcea Therapeutics (NASDAQ:AKCA) should first plan for a Phase III study for AKCEA-APO(a)-LRx to determine the exact levels of lipoprotein Lp(a) reduction and cardiovascular (CV) risk before proceeding to a cardiovascular outcome trial (CVOT), experts said.

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