Product Development

Roche’s APHINITY results in high-risk breast cancer subset still unlikely to preserve original enthusiasm

Roche’s (VTX:ROG) slim benefit with Perjeta (pertuzumab) in the APHINITY trial in Her2+ breast cancer has experts predicting a smaller than anticipated market use in the adjuvant setting including the more hopeful higher risk subset.

Roche had earlier announced the trial reaching its primary endpoint on 2 March, leading to an upward share price movement of 6.5% and expectations of Perjeta being added to the standard of care -- Roche’s (VTX:ROG) Herceptin (trastuzumab) and chemotherapy -- for adjuvant therapy in Her2+ patients.

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Eli Lilly’s Cyramza may see steady uptake due to clinician familiarity if approved for first-line gastric cancer; to be used in combo with FOLFOX

Eli Lilly's (NYSE:LLY) Cyramza (ramucirumab) will likely have limited uptake issues in most patients if it shows positive Phase III results in first-line gastric cancer due to clinicians' familiarity with second-line use of the drug, experts said.

Physicians' familiarity could boost their confidence in prescribing the drug and make predicting potential side effects easier, some experts noted.

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Gottlieb’s leadership to see cell therapies, generics hit the market faster, but budget, staffing challenges remain

Faster drug approval for cell therapies and a clearance of the backlog of generic approval applications are the expected positive outcomes for the drug industry following the appointment of FDA Commissioner Scott Gottlieb on 11 May, experts said. Despite having to contend with a tight budget and insufficient staffing - perennial FDA problems-- his pragmatic, science-based approach to regulatory review and the possibility of hiring more staff through the 21st Century Cures Act are encouraging for better market access, they said.

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PD-1/PD-L1 inhibitor use leading to hyperprogression calls for caution, biomarker search

The prevalence of hyperprogressive disease (HPD) among patients receiving PD-1/PD-L1 checkpoint inhibitors and its relationship to MDM2 amplification underscores the need for caution with widespread prescription of the blockbuster drugs and the need for biomarkers to predict HPD, experts said.

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Puma’s neratinib AdCom unlikely to be thwarted by Roche’s APHINITY win; ER+ niche may find takers but an uphill task – experts

Puma Biotechnology's (NASDAQ:PBYI) neratinib FDA advisory committee (AdCom) review and approval chances in the extended adjuvant setting will unlikely be impacted by Roche's (VTX:ROG) Phase III Perjeta (pertuzumab) data in the adjuvant setting for Her2+ breast cancer, said experts.

However, during the 24 May AdCom review, Puma will face questions on data integrity of its Phase III pivotal ExteNET study (NCT02400476), since the trial design was changed through the course of the study and because of its Grade 3 diarrhea side-effect profile, said experts.

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Tau-targeting drugs hold rationale for AD, however concerns including optimal approach and patient selection remain – experts

Tau-targeting drugs have sparked debate for their potential to treat Alzheimer's disease (AD) with experts weighing up strong pathological rationale with concerns regarding scant clinical data, patient selection and whether antibody or vaccines are the best approach.

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Celgene’s marizomib sees Phase I/II recurrent GBM study on hold pending protocol amendment to expand enrollment – sources

Celgene's (NASDAQ:CELG) Phase I/II study of marizomib in combination with Roche's (VTX:ROG) Avastin (bevacizumab) in recurrent glioblastoma (GBM) is awaiting a protocol amendment to allow expansion of 40 additional patients, two sources said. The current study is on hold, added one source, despite the trial being listed as recruiting on ClinicalTrials.gov.

The current enrollment target is 66 patients, according to the trial's (NCT02330562) ClinicalTrials.gov page, which was last updated on 4 January and shows a July 2017 primary completion date.

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Gilead’s Phase II NASH drug expected to prove safe but limited data draws caution, MOA rationale for early efficacy signals – experts

Gilead Sciences' (NASDAQ:GILD) Phase II trial investigating GS-0976 for nonalcoholic steatohepatitis (NASH) has drawn cautious safety optimism from experts. Whilst available 10 subject data is too small to draw conclusions, GS-0976 mechanism does not elicit safety concerns, they added. But one expert noted the drug's downstream target could lead to side effects related to elimination of fat in the liver.

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GSK’s closed triple in COPD faces pulmonologist resistance on ICS use but GP generous prescribing to drive market

GlaxoSmithKline’s (LON:GSK) closed triple FF/UMEC/VI combination carries dampened enthusiasm for use in chronic obstructive pulmonary disease (COPD)with questionable risk/benefit profile of the inhaled corticosteroid (ICS), experts said.

The closed triple is a once-daily inhaler with an inhaled corticosteroid (ICS)/long acting muscarinic antagonist (LAMA)/ long acting beta agonist (LABA) combination of GSK’s Flovent (fluticasone), Incruse (umeclidinium) and vilanterol, respectively.

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BioMarin’s pegvaliase for PKU will likely remain second to Kuvan at initial launch, eventual uptake certain with unmet need, diet noncompliance – experts

BioMarin Pharmaceutical's (NASDAQ:BMRN) PEG-PAL (pegvaliase) if approved has most experts noting that it will initially remain second-line as an option for adult standard of care (SOC) for phenylketonuria (PKU) versus Kuvan (sapropterin). Kuvan’s preferable side-effect profile and physician experience, among other reasons, will have it maintain its first-line status, they said.

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