COVID-19 vaccines bring a potential end to the pandemic into sight
Positive data have continued to accumulate for the most advanced COVID-19 vaccine candidates, building on Pfizer and BioNTech's announcement last week that BNT162b2 was shown to be more than 90% effective at the first interim analysis of Phase III data (see Friday Five – The pharma week in review (13 November 2020)).
On Wednesday, the two companies subsequently confirmed that final Phase III data show BNT162b2 to be 95% effective at preventing COVID-19. Importantly, results also show the efficacy was more than 94% in adults aged over 65.
On Monday, Moderna released interim results for its vaccine mRNA-1273, showing an efficacy rate of 94.5%. Both vaccines have been developed using novel mRNA technology.
Phase III data for the vaccine being developed under collaboration between AstraZeneca and the University of Oxford, which uses a novel chimpanzee adenovirus vector, is expected to read out before the end of the year.
On Thursday, Andrew Pollard, study lead at the University of Oxford, said he was "absolutely delighted" that a new analysis of Phase II data shows that the vaccine appears to elicit a strong immune response in adults aged 60 and upwards.
Survey results: Emerging impact from second wave on physician-patient interaction
In the meantime, the fourth iteration of our survey tracking trends in physician-patient interaction rates during the COVID-19 pandemic (fielded to 1014 physicians across 10 countries between October 25 and November 5) shows that an emerging second wave of infections is starting to have a negative impact on face-to-face patient meetings.
Our latest survey shows that 88% of respondents indicated that they had met with at least one patient face-to-face in their office or clinic over the past week, versus 92% in our last survey, which was fielded in July. Surveys fielded in May, June and July had shown a steady uptick in face-to-face interactions as the impact of the pandemic subsided during the summer months in the Northern hemisphere.
Similarly, the proportion of physicians who have met face-to-face with at least one patient in a hospital setting over the past seven days has also declined slightly, from 59% in July to 56% in October.
Amazon primed for pharmacy expansion
In a move that prompted the share price of rival drug retailers to fall, Amazon announced this week the launch of Amazon Pharmacy, which allows customers in the US to complete an entire pharmacy transaction on their desktop or mobile device through the Amazon app. In 2018, Amazon acquired the full-service online pharmacy company PillPack for $753 million.
Launch of Amazon Pharmacy expands the company's pharmacy offering to Amazon.com and allows Amazon Prime members to receive unlimited, free two-day delivery on orders included with their membership. Members can also access savings on medications at Amazon Pharmacy when paying without insurance, as well as at over 50,000 other participating pharmacies. According to the company, the Amazon Prime prescription savings benefit will save members up to 80% off generic drugs and 40% off brand-name medications when paying without insurance. More here.
FirstWord's Tina Tan notes "the convenience of being able to buy your medications online not only makes for a more appealing alternative than queuing up at the drugstore, but it also presents a timely solution in the current COVID-19 environment. Furthermore, elderly patients more likely to be on multiple drug regimens and with a need for regular prescription refills could benefit from Amazon's PillPack offering, which simplifies medication management through convenient dose packaging."
She adds that Amazon could also be looking to integrate its other healthcare capabilities as a means to enhance services offered by Amazon Pharmacy, noting that last year it acquired Health Navigator, a software company specialising in developing tools for enabling telemedicine. Amazon could be using these capabilities to develop virtual symptom checkers and health chat bots, which would sit nicely within a pharmacy setting and add to the customer experience.
Another hold up for Celgene shareholders looking to cash in their CVR pay-outs
The FDA has informed Bristol Myers Squibb that its review of the investigational CAR-T therapy lisocabtagene maraleucel for the treatment of adults with relapsed or refractory large B-cell lymphoma after at least two prior therapies will not be completed by an already extended deadline of November 16, the company announced Monday. US approval of the CD19-directed CAR T-cell therapy by December 31 is one of three required milestones of the contingent value rights (CVR) issued upon the close of Bristol Myers Squibb's $74-billion acquisition of Celgene late last year.
The CVR would entitle Celgene shareholders to receive a one-time potential payment of $9 per share in cash upon FDA approval of three therapies in specific indications and by certain deadlines. One of the treatments, the S1P receptor modulator Zeposia (ozanimod), was cleared by the agency in March for adults with relapsing forms of multiple sclerosis.
The other remaining milestone of the CVR is US approval of the BCMA-directed CAR T-cell immunotherapy idecabtagene vicleucel by the end of March 2021. That therapy, also known as bb2121, is currently undergoing priority review by the FDA for the treatment of adults with multiple myeloma who have received at least three prior therapies. A decision is expected by March 27 of next year.
Merck & Co.'s Keytruda achieves first approval for breast cancer
Late last week, the FDA announced that it awarded accelerated approval to Merck & Co.'s Keytruda for use in combination with chemotherapy to treat patients with locally recurrent, unresectable or metastatic triple-negative breast cancer (TNBC) whose tumours express PD-L1 with a combined positive score (CPS) of 10 or greater. This represents the first approval of Keytruda in the breast cancer setting.
The decision was based on results from the Phase III KEYNOTE-355 study evaluating Keytruda in combination with physician's choice of chemotherapy versus placebo plus chemotherapy, as a first-line treatment for patients with metastatic TNBC.
Results show that among patients whose tumours expressed PD-L1 with CPS of at least 10, Keytruda plus chemotherapy led to a significant and clinically meaningful improvement in progression-free survival (PFS), reducing the risk of disease progression or death by 35% and improving PFS to a median of 9.7 months, compared to 5.6 months for those on chemotherapy alone.
Keytruda will compete against Roche's PD-L1 inhibitor Tecentriq in this market, but Merck appears to hold a notable advantage. Versus evidence showing a PFS benefit for Keytruda when used with physician's choice of chemotherapy, Tecentriq is only approved to treat PD-L1 positive metastatic TNBC patients in combination with Abraxane. Furthermore, Tecentriq failed to show a PFS benefit when used with paclitaxel.
Keep an eye out for – KOL Views: Has Keytruda’s arrival shifted the balance of power in TNBC?
To read more Friday Five articles, click here.