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 AstraZeneca, which is working on the drug with Japan's Daiichi
Sankyo, said on Monday that Enhertu prolonged survival and slowed
the progression of metastatic breast cancer with low levels of a
protein known as HER2.
The improvement was "clinically meaningful" when compared with
standard chemotherapy, it said, adding that detailed results of the
late-stage trial would be presented at an as-yet undisclosed medical
conference.
The company said it would reach out to regulatory agencies to enable
a speedy review of a wider use for the drug.
While the study was limited to low-HER2 patients whose tumours had
spread to other parts of the body, analysts have said a positive
trial read-out could portend future use at earlier stages of the
disease with potentially hundreds of thousands of new eligible
patients per year.
The read-out is set to bolster the Anglo-Swedish company's status
among analysts as one of the world's fastest growing major pharma
groups, thanks to a high success rate in cancer drug development.
It has forecast higher group revenues for 2022, despite a decline in
sales of its widely used COVID-19 vaccine, driven by cancer drugs
such Tagrisso against lung tumours and treatments for kidney disease
and rare conditions.
The company's shares were up 2.1% at 1044 GMT, outperforming a 0.15%
increase in the STOXX Europe 600 Health Care index and extending a
5% gain over the previous four trading sessions.
"HER2 low is a large and previously unaddressed patient pool in
breast cancer," analysts at Credit Suisse said in a note, adding
they saw a 50% probability of $3 billion peak sales potential from
the new patient group.
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AstraZeneca secured rights to the Daiichi Sankyo
compound three years ago in a deal worth up to
$6.9 billion. Enhertu has since been shown to
help women with metastatic breast cancer
characterised by high levels of HER2 when
compared to Kadcyla, the ADC drug from
Switzerland's Roche - the world's biggest cancer
drug maker.
"This is about redefining the categorisation of
breast cancer and increasing the number of options for women," said
Susan Galbraith, Astra's head of oncology research and development.
She added that, while the new study had focused on women that had
exhausted three to four earlier therapies, more trials would in
future test Enhertu on women during earlier stages of the disease,
both with high and low HER2, which would be a much larger patient
group.
Enhertu belongs to a promising class of therapies called antibody
drug conjugates (ADC), which are engineered antibodies that bind to
tumour cells and then release cell-killing chemicals.
This led to initial market approval in late 2019. A further
clearance was won for HER2-driven gastric cancer. The drug is also
being tested against other forms of gastric, lung and colorectal
cancers.
Roche's established Herceptin drug is also based on the HER2
receptor but Enhertu is designed to pack a much larger cell-killing
punch so that even low levels of HER2 enable treatment.
($1 = 0.9183 Swiss francs)
(Additional reporting by Pushkala Aripaka in Bengaluru; editing by
Shounak Dasgupta, Jason Neely, Kirsten Donovan)
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