Product Development

Merck KGaA’s and Novartis’ Phase II drugs for MET exon 14 skipping mutation require diagnostic adjustments to spur use, experts say

Improving patient identification tools will be key to getting full market traction for Merck KGaA’s (ETR:MRK) tepotinib and Novartis’ (SIX:NOVN) capmatinib after an expected approval in non-small cell lung cancer (NSCLC) patients with MET exon 14 skipping mutations, experts said. Presentations at ASCO earlier in June on initial Phase II data for both drugs were impressive, however, with experts citing interest in using the drug in the first-line (1L) setting.

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Amgen’s AMG510 clinical data deemed encouraging for NSCLC on ASCO update with single-agent potential; CRC data disappointing but higher dose awaited, experts say

Amgen’s (NASDAQ:AMGN) Phase I/II AMG510 efficacy data in non-small cell lung cancer (NSCLC) improves expert outlook on its KRAS G12C inhibition mechanism’s potential as a single agent, experts said. However, some expert caution remains due to currently poor colorectal cancer (CRC) data in the same trial, and overall low patient numbers for both indications.

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Amarin’s Vascepa, AstraZeneca’s Epanova theoretical CVD risk reduction class effect possibly stifled by Epanova’s DHA ingredient, experts say

Although Amarin’s (NASDAQ:AMRN) Vascepa (icosapent ethyl) is likely to lock in FDA approval and swift uptake in cardiovascular disease (CVD) risk reduction, there could be future competition with AstraZeneca’s (LON:AZN) Epanova (omega-3-carboxylic acids), experts said. A potential class efficacy/safety effect is possible as both therapies are approved for hypertriglyceremia, but Epanova’s dissimilar ingredient list could be a key differentiating element, they added.

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PFIC patient variation to stifle SOC label domination by either Albireo’s odevixibat or Mirum’s maralixibat; differentiation still nebulous, investigators say

Heterogeneity among progressive familial intrahepatic cholestasis (PFIC) types 1 and 2 patients is likely to impede both Albireo Pharma’s Phase III odevixibat and Mirum Pharmaceuticals’ Phase III maralixibat in claiming standard-of-care designation for this rare liver disease, investigators said. With both odevixibat and maralixibat having a comparable mechanism and limited available data, it is unclear whether either have differentiating features to identify the subpopulations where they would flourish, they added.

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Minerva’s MIN-101 Phase III design and MOA prompt skepticism in schizophrenia, selective inclusion criteria raise questions on approvability and uptake, experts say

Minerva Neurosciences’ (NASDAQ:NERV) MIN-101 (roluperidone) has experts skeptical of Phase III success treating negative symptoms of schizophrenia, despite having positive Phase IIb data. While roluperidone has a similar trial design with its successful earlier trial—lending some optimism—questions about its inclusion criteria, mechanism of action (MOA) and the inherent high placebo rate of schizophrenia trials preclude strong confidence, they said.

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Immunomedics’ sacituzumab still has reasonable shot of carving market territory in second- or third-line UC even if later arrival than Astellas’ enfortumab vedotin, experts say

Although Immunomedics’ (NASDAQ:IMMU) sacituzumab govitecan is likely to reach the second- and third-line urothelial carcinoma (UC) market behind Astellas Pharma’s (TYO:4503) enfortumab vedotin (EV), both therapies are likely to have notable impact in UC, experts said. Differing antibody-drug components, toxicity profiles and dosing schedules could allow sufficient uptake for each, they said, which is in contrast to analysts’ contradictory market estimations.

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Pfizer’s Xeljanz RA safety alert prompts physician caution in 10mg BID dose in risky UC group, with potential dose avoidance and schedule changes

Pfizer’s (NYSE:PFE) Xeljanz (tofacitinib) safety alert in rheumatoid arthritis (RA) patients could lead to exclusion of riskier ulcerative colitis (UC) patients from receiving the 10mg BID dose, some experts said, while others noted the need for more data to influence treatment decisions.

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Regeneron’s Dupixent better meets the moderate-to-severe atopic dermatitis market’s needs compared to AnaptysBio, Dermira’s investigational therapies, experts say

Regeneron Pharmaceuticals’ (NASDAQ:REGN) Dupixent (dupilumab) is likely to maintain its foothold in moderate-to-severe atopic dermatitis (AD) in the foreseeable future considering the therapies currently under investigation seem to fall short in delivering any clinically relevant added efficacy/safety benefit, experts said. In contrast, analysts forecast billion-dollar peak sales estimates for treatments like AnaptysBio’s (NASDAQ:ANAB) Phase IIb etokimab based on the possibility of the therapy having at least similar efficacy to Dupixent.

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Myovant’s relugolix’s supposed market edge in castrate-sensitive prostate cancer draws expert reservations, even with likely Phase III success and approval

Myovant Sciences’ (NYSE:MYOV) relugolix’s clinical advantages might not be impactful enough to support uptake in castrate-sensitive prostate cancer, experts said. This is in contrast to analysts’ positive market sentiments based on relugolix’s oral administration and its efficacy potential in rapidly altering testosterone levels and preventing testosterone flares. Nonetheless, experts noted relugolix's likely Phase III success and FDA approval are supported by clinically relevant Phase II data.

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Veru’s Phase II VERU-944 for hot flashes due to prostate cancer treatment needs gynecomastia, CVD risk monitoring, experts say

Veru’s (NASDAQ:VERU) Phase II VERU-944 (zuclomiphene citrate) for moderate-to-severe vasomotor symptoms (hot flashes) in patients taking androgen-depravation therapy (ADT) for advance prostate cancer could induce gynecomastia—enlargement of the male breast gland—due to the treatment’s mechanism of increasing estrogen levels, experts said. Long-term, cardiovascular disease (CVD) risk should be monitored based on estrogen-based therapies that have such side effects, others added.

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