AstraZeneca gets two EMA recommendations, enters oncology partnership
AstraZeneca shareholders were met with a raft of updates from the company on Monday morning, including two positive recommendations from the European Medicines Agency, and the announcement of a new oncology collaboration.
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The FTSE 100 firm told markets that ‘Imfinzi’, or durvalumab, has been recommended for marketing authorisation in the European Union for the first-line treatment of adults with extensive-stage small cell lung cancer, in combination with a choice of chemotherapies, etoposide plus either carboplatin or cisplatin.
It described small cell lung cancer as a “highly aggressive, fast-growing” form of lung cancer that typically recurred, and progressed rapidly despite initial response to chemotherapy.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on results from the phase 3 ‘CASPIAN’ trial for Imfinzi plus chemotherapy, which was published in the Lancet.
AstraZeneca said the trial showed that Imfinzi plus chemotherapy demonstrated a “statistically significant and clinically meaningful” overall survival benefit for the first-line treatment of patients with ES-SCLC, reducing the risk of death by 27% compared to chemotherapy alone.
The results also showed an increased confirmed objective response rate in the Imfinzi plus chemotherapy arm at 68%, versus 58% for chemotherapy alone, and that Imfinzi added to chemotherapy delayed the time it took for lung cancer-related symptoms to worsen.
“Imfinzi has the potential to address a critical unmet need for patients with extensive-stage small cell lung cancer in Europe who have few options to treat this aggressive and devastating disease,” said José Baselga, executive vice-president of oncology research and development.
“We look forward to delivering a new standard of care that significantly improves survival with a choice of chemotherapies and convenient dosing every four weeks during maintenance.”
At the same time, AstraZeneca said ‘Calquence’, or acalabrutinib, has been recommended for marketing authorisation in the EU for the treatment of adult patients with chronic lymphocytic leukaemia - the most common type of leukaemia in adults.
The CHMP based its positive opinion on results from two phase 3 clinical trials, ‘ELEVATE TN’ in patients with previously untreated chronic lymphocytic leukaemia, and ‘ASCEND’ in patients with relapsed or refractory chronic lymphocytic leukaemia.
In the ELEVATE TN trial, Calquence combined with obinutuzumab and as monotherapy reduced the risk of disease progression or death by 90% and 80%, respectively, compared to standard chemo-immunotherapy treatment chlorambucil plus obinutuzumab, in patients with previously-untreated chronic lymphocytic leukaemia.
Meanwhile, in the ASCEND trial, 88% of patients with relapsed or refractory chronic lymphocytic leukaemia taking Calquence remained alive and free from disease progression after 12 months, compared to 68% of patients on rituximab combined with idelalisib or bendamustine.
Across both trials, the safety and tolerability of Calquence were consistent with its known profile, the company confirmed.
“With its outstanding efficacy and tolerability profile, Calquence can offer important advantages to patients with chronic lymphocytic leukaemia who are typically older, facing multiple comorbidities and often require treatment for many years,” said José Baselga.
“This positive recommendation brings us closer to providing a much-needed new treatment option to patients in Europe who are suffering from this chronic blood cancer.”
Finally, AstraZeneca said it had entered into a new global development and commercialisation agreement with Daiichi Sankyo Company for ‘DS-1062’ - Daiichi Sankyo's proprietary trophoblast cell-surface antigen 2-directed antibody drug conjugate, and potential new medicine for the treatment of multiple tumour types.
The firm said DS-1062 was currently in development for the treatment of multiple tumours that commonly expressed the cell-surface glycoprotein TROP2.
Among them, TROP2 was overexpressed in the majority of non-small cell lung cancers and breast cancer tumour types that had long been a strategic focus for AstraZeneca.
“We see significant potential in this antibody drug conjugate in lung as well as in breast and other cancers that commonly express TROP2,” said chief executive officer Pascal Soriot.
“We are delighted to enter this new collaboration with Daiichi Sankyo and to build on the successful launch of Enhertu to further expand our pipeline and leadership in oncology.
“We now have six potential blockbusters in oncology with more to come in our early and late pipelines.”
At 0855 BST, shares in AstraZeneca were down 0.0009% at 8,651.93.