Product Development

Evofem’s Phase III Amphora contraceptive draws expert doubt on pregnancy-prevention potential with trial variables and compliance; more utility in STI prevention

Evofem Bioscience’s (NASDAQ:EVFM) Phase III Amphora (L-lactic acid, citric acid, and potassium bitartrate) has experts apathetic about its prospects in preventing pregnancies. The drug’s similarities to spermicide, which has questionable efficacy, is subduing confidence along with multiple variables and room for error with this trial design.

Experts remain concerned about how the drug’s user failure rate will translate to a Phase III US population, with early data already indicating a higher level of improper use in this cohort.

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Novavax’s RSV F vaccine has experts uncertain about Phase III trial outcome with insufficient primary endpoint and earlier results that cannot be extrapolated

Novavax’s (NASDAQ:NVAX) Phase III trial for respiratory syncytial virus (RSV) F vaccine for maternal immunisation has experts uncertain on expected trial outcomes due to the inadequacy of the primary endpoint and difficulty extracting conclusions from earlier data. Whilst three experts said the trial has targeted the appropriate population, another said it would have been better to target more specific subgroups.

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AbbVie/J&J’s Imbruvica has 90% seven-year PFS rate in low-risk CLL patients and 30%–40% for high-risk patients, source says

A 7.5-year follow-up of AbbVie (NYSE:ABBV) and Johnson & Johnson’s (NYSE:JNJ) Imbruvica (ibrutinib) for chronic lymphocytic leukemia (CLL) found that the seven-year progression-free survival (PFS) rate is over 90% for low-risk patients and 30%–40% for high-risk patients, a source with knowledge of the situation said.

Results are part of an abstract that is expected to be presented at the 2018 ASH meeting in December, the source added. Reached for comments, AbbVie's Pharmacyclics and Johnson & Johnson's (J&J's) Janssen Pharmaceutical did not respond.

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Akcea’s Phase II FPL trial underpowering, design flaws leave experts skeptical of AKCEA-ANGPTL3-LRx study success

Akcea Therapeutics’ (NASDAQ:AKCA) Phase II trial of AKCEA-ANGPTL3-LRx is insufficiently powered to meet its primary efficacy endpoint for familial partial lipodystrophy (FPL), experts said. Other design aspects as well as earlier Phase I/II data also do not give them confidence that the trial will succeed, they added.

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BMS’ Opdivo/Yervoy 1L maintenance therapy relevance to be clouded by Roche’s SOC-changing IMpower 133 results, experts say

Bristol-Myers Squibb’s (NYSE:BMY) bid for Opdivo (nivolumab) and Yervoy (ipilimumab) as a maintenance therapy following chemotherapy in small cell lung cancer (SCLC) will likely be thwarted by the expected addition of Roche’s (SIX:ROG) Tecentriq (atezolizumab) to the first-line (1L) setting, experts said.

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ObsEva’s Phase III IVF study of nolasiban draws expert skepticism on use of too many trial sites for clean data

ObsEva’s (SIX:OBSN) Phase III study of OBE001 (nolasiban) in improving pregnancy rates via in vitro fertilization (IVF) has experts question its use of greater than 40 trial centers. Inherent differences among physician techniques could result in challenges to demonstrating clean data, they added.

Further muddying the Phase III IMPLANT trial (NCT03081208) outcome is the drug’s failure to meet its Phase II primary endpoint and uncertainty on the oxytocin receptor targeting mechanism, experts added.

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Celgene’s JCAR017 for r/r DLBCL likely to pass Phase II test but edge over approved CAR-Ts questioned, experts say

Celgene’s (NASDAQ:CELG) CAR-T cell therapy JCAR017 for relapsed or refractory (r/r) diffuse B-Cell lymphoma (DLBCL) will likely succeed in its Phase II PLATFORM trial based on available efficacy data, experts said. However, as a third-to-market CAR-T therapy in DLBCL, experts question its ability to yield an advantage worthy of meaningful market pursuit.

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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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