We break down five key pharma news stories in a week that was dominated by the FDA's controversial approval of Biogen's Aduhelm and the annual meeting of the American Society for Clinical Oncology (ASCO).
Aducanumab controversy #1 – approval
- The FDA approved Biogen's Aduhelm (aducanumab) on Monday for the treatment of Alzheimer's disease.
- It is described as potentially being the first and only disease modifying Alzheimer's treatment, though this has yet to be definitively proven by two large Phase III studies. In November, an FDA advisory committee voted near unanimously against approving Aduhelm; two of its panellists have quit their roles on the committee following Monday's announcement.
- Adding further controversy, the FDA approved Aduhelm with an exceptionally broad label as a treatment for all Alzheimer's disease patients, despite Biogen's Phase III studies evaluating the drug only in early-stage patients with mild-cognitive impairment.
- Accelerated approval has been granted, meaning that the FDA can withdraw authorisation if confirmatory data does not show a benefit, but Biogen has nine years to complete a post-marketing study.
Aducanumab controversy #2 – pricing
- Adding fuel to the fire, Biogen has priced Aduhelm at a wholesale acquisition cost of $56,000 per year , well above what analysts had anticipated.
- Furthermore, with Aduhelm approved under the FDA's accelerated pathway, this will shift considerable financial burden onto Medicare.
- Our snap-poll of 40 Alzheimer's disease-treating physicians (who are split on whether the FDA had done the right thing in approving Aduhelm ) suggests that on average 30% of patients with beta-amyloid plaques could be treated with the drug.
- Given the size of the US Alzheimer's disease population, this would significantly reshape Biogen's growth outlook.
More Aduhelm analysis –
ViewPoints: Barn door swings wide open in Alzheimer’s and beyond
ViewPoints: Projecting the fallout from FDA’s divisive Aduhelm approval
ViewPoints: Will Biogen’s attempt to shift debate on Aduhelm pay off?
Cancer therapies move upstream at ASCO
- Feedback from oncologists suggests that comfort towards treating earlier-stage cancer patients with immunotherapies or targeted drugs is growing on the back of new clinical data presented this past weekend at ASCO.
- This despite concerns among some experts that while early-stage clinical endpoints, such as disease-free survival (DFS), demonstrate whether a patient has avoided disease recurrence for a period of time, they do not show to what extent they benefit from longer overall survival (OS).
- This Twitter poll with around 300 respondents by oncologist Eva Segelov from Monash University indicates that cancer specialists are split on whether to wait for OS data before prescribing therapies in earlier-stage patients.
- However, when presented with specific clinical data from the IMpower010 study (evaluating Roche's Tecentriq in adjuvant PD-L1 positive non-small cell lung cancer) and the OlympiA study (evaluating AstraZeneca and Merck & Co'’s PARP inhibitor Lynparza in adjuvant BRCAm breast cancer), oncologists are much more effusive about their willingness to use.
See also – KOL Views Q&A: Roche’s Tecentriq lays impressive marker but all still to play for in perioperative NSCLC, says leading oncologist
And elsewhere from ASCO… Physician Views Results: Novartis’ Lu-PSMA-617 backed as a useful new treatment option for prostate cancer
A closer look at LAG-3
- We have reiterated in recent weeks that presentation of clinical data from Bristol Myers Squibb's RELATIVITY-047 study would be one of the standout presentations at ASCO, but had flown somewhat under the radar – despite this trial validating LAG-3 (via the novel drug relatlimab) as only the third checkpoint inhibitor target.
- Our recent oncologist survey suggested the combination of relatlimab and Opdivo could potentially be a better treatment option than Opdivo/Yervoy for melanoma patients and we are pleased to announce a live conversation with a leading melanoma expert will take place next week to discuss this target further – more here .
Could Bristol Myers Squibb's Zeposia benefit form JAK caution in UC?
- Uncertainty around the future role of JAK inhibitors to treat ulcerative colitis could help Bristol Myers Squibb's newly approved Zeposia (an S1P receptor modulator) gain market share, a gastroenterology KOL told FirstWord this week.
- The expert noted that Zeposia offers an attractive combination of efficacy and safety with the convenience of an oral medication
- This could make it a favoured treatment option in biologic-naïve patients, but US insurers may challenge this and require patients to be treated first with a biosimilar anti-TNF, he added. More on Zeposia and its potential role in UC here .