We break down five of the week's most important news stories.
For further analysis, listen to the latest episode of The FirstTake podcast here .
- Bernstein analyst Ronny Gal says that Pfizer and BioNTech's COVID-19 vaccine Comirnaty is now on track to generate sales of around $70 billion by the end of next year.
- He has upped his forecasts following a recent contract signed by the EU for 1.8 billion doses of Comirnaty – enough to vaccinate the bloc's population four-times over.
- With its coffers swelled, Pfizer could become an aggressive player in the M&A field. More here .
NGM goes out in a whimper in NASH
- A few years ago, new treatments for non-alcoholic steatohepatitis (NASH) were heralded as a huge opportunity for drug developers. However, clinical development has so far failed to meet expectations. The latest casualty is NGM Biopharmaceuticals' aldaferin.
- Phase II results have prompted NGM to scale back development of the compound and its focus on NASH as a disease area of interest, the company announced this week.
- Confirmation of another setback in the field may raise further question marks about the potential role of fibrosis as a predictive endpoint , a school of thought that could have profound implications for a host of other developers.
Replicating Cabometyx’s success in prostate cancer may prove challenging
- Exelixis and Ipsen's targeted cancer therapy Cabometyx has become an important treatment option for renal cell carcinoma patients, but efforts to secure approval in prostate cancer may prove challenging .
- Shrugging off concerns about new response rate data in high-risk patients, Exelixis maintains it is on track to discuss an accelerated approval with the FDA.
- Investors will have one eye on next weekend's ASCO annual meeting, however, where results from the Phase III VISION study evaluating Novartis' radioligand therapy Lu-PSMA-617 will be presented as one of the meeting's late-breaking abstracts. Novartis has previously disclosed that overall survival and radiographic progression-free survival endpoints have been met .
See also – KOL Views Q&A: Leading urologist sees Novartis’ radioligand moving earlier in prostate cancer if safety stays in check
Tirzepatide clears final pre-regulatory hurdle
- After Biogen and Eisai's aducanumab (awaiting potential, and what would be highly controversial, US approval for Alzheimer's disease), Eli Lilly's experimental diabetes treatment tirzepatide is forecast to be the industry's second biggest selling pipeline drug.
- The company can now proceed with regulatory applications for tirzepatide, a first-in-class GIP/GLP-1 receptor agonist, having confirmed – as expected – a meaningful cardiovascular risk reduction versus insulin .
- Whether tirzepatide can match the impressive cardiovascular benefit demonstrated by the GLP-1 class will only become apparent when data from a larger outcomes study reads out in 2024.
- Our physician survey results indicate that some endocrinologists will be more cautious towards prescribing tirzepatide before these data are available, but nevertheless suggest that the drug will live up to commercial expectations based on impressive Phase III data.
See – FirstImpact Results – Three reasons why tirzepatide will be a game-changer in diabetes
More momentum for AbbVie’s ADC aspirations in RA
- AbbVie has posted details of a Phase II study evaluating ABBV-154, an antibody-drug conjugate (ADC) comprised of a novel glucocorticoid receptor modulator (GRM) linked to a TNF-inhibitor.
- ABBV-154 is one of two ADCs being developed for rheumatoid arthritis (RA) by AbbVie and likely the preferred agent to move into late-stage testing. Last year, the company confirmed positive top-line data for its other candidate ABBV-3373 in a Phase IIa study versus Humira, with detailed results expected this year.
- AbbVie's new study for ABBV-154 is a dose-finding, proof-of-concept study that will enrol 425 RA patients. It will evaluate three doses of the ADC (one of which will be dosed every other week and every four weeks) with primary endpoint data (ACR50 at 12 weeks) expected in November 2022.
See also – ViewPoints: AbbVie looks to bring ADCs to rheumatology