BioNTech and Pfizer released new data this week suggesting that the COVID-19 vaccine BNT162b2 is capable of neutralising the SARS-CoV-2 variant B.1.1.7. which is thought to have originated in the UK.
The companies say they are "encouraged" by the new study, but cautioned that more data are needed to monitor the vaccine's effectiveness at preventing COVID-19 caused by new variants. It is not yet clear what level of reduced efficacy would warrant a vaccine strain change, but they indicated that should such a change be necessary in the future, "the flexibility of BioNTech's proprietary mRNA vaccine platform is well suited to enable such adjustment."
Eli Lilly also announced on Thursday that in a Phase III study, its antibody drug bamlanivimab was shown to significantly reduce the risk of contracting symptomatic COVID-19 among residents and staff of long-term care facilities. Findings from the BLAZE-2 COVID-19 prevention trial suggest the risk was decreased by up to 80% in people administered the antibody therapy versus those in the same facility given placebo.
Bamlanivimab is currently authorised for emergency use in the US for the treatment of mild-to-moderate COVID-19 in high-risk patients and Lilly said it will now work "with regulators to explore expanding the emergency-use authorisation to prevent the spread of COVID-19 in these facilities." To what extent the roll-out of vaccines could limit the role of antibody drugs as preventative therapies remains unclear at present and both AstraZeneca and Regeneron are evaluating antibody-based therapies in a preventative setting also.
Expert quote of the week
“It's a small sample size, so it's very difficult to make global overarching statements. The best you can say is, ‘Let's keep looking and see what happens’, but it gives me pause to ask, ‘Are we going in the right direction?’"
We discussed recently announced Phase II data for Sarepta’s investigational Duchene muscular dystrophy (DMD) gene therapy with a leading KOL this week. He thinks developers could be at least two to three years away from generating sufficient data to ascertain whether gene therapy will represent a safe and viable approach to treating DMD.
Detailed Phase III results for tezepelumab, a novel biologic therapy for severe asthma being co-developed by Amgen and AstraZeneca will be presented at some point in the next few months, possibly at the annual meeting of the American Thoracic Society (ATS) in May.
We have run a number of recent pulmonologist surveys to benchmark the efficacy (reduction in exacerbations) tezepelumab will need to demonstrate if it is to carve out use across a broad cohort of severe asthma patients, including those with lower blood eosinophil counts where available treatments are less effective.
Results from our latest survey, which were published this week, suggest the onus on these data have increased following confirmation in late December that a second late-stage study showed that tezepelumab failed to reduce oral corticosteroid (OCS) use in certain patients.
Keytruda sees off another competitor
A bold strategy instigated by Merck KGaA to disrupt the lung cancer market has failed, the German company announced this week. The company confirmed on Wednesday that an independent data monitoring committee (IDMC) has recommended that it halt a head-to-head study evaluating the bi-functional antibody bintrafusp alfa against Merck & Co.’s PD-1 inhibitor Keytruda in metastatic non-small cell lung cancer (NSCLC) patients who are high expressers of PD-L1. Bintrafusp alfa targets PD-L1 and TGF-beta.
Development of bintrafusp alfa continues across a number of other tumour types and a Phase III study in Stage III NSCLC is also ongoing. However, demonstration of superiority against Keytruda in metastatic patients represented the biggest commercial opportunity for bintrafusp alfa and would have also provided Merck KGaA and its co-development partner GlaxoSmithKline significant R&D kudos.
Approval in focus – Enhertu
Partners AstraZeneca and Daiichi Sankyo announced on Wednesday that conditional European approval has been granted to Enhertu as a monotherapy for the treatment of adults with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens. The antibody-drug conjugate (ADC) is already authorised for this indication in the US and Japanese markets.
Enhertu is notably the first-ever new medicine to be approved in breast cancer in Europe on the basis of Phase II single-arm data, the companies noted. It has demonstrated an objective response rate of 61.4% in the third-line setting.
A first European approval also comes days after the US FDA granted earlier than expected approval of Enhertu for the treatment of HER2-positive gastric or gastroesophageal (GEJ) adenocarcinoma previously treated with a Herceptin-based regimen.
AstraZeneca paid Daiichi $1.4 billion upfront as part of a deal potentially worth $6.9 billion to jointly develop and commercialise Enhertu across multiple indications. Further pivotal-data readouts are anticipated as the year progresses including results in HER2-positive NSCLC in mid-2021 and HER2-low breast cancer in the second half.
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