Collaboration with Daiichi Sankyo
On March 28, AstraZeneca (AZN) issued a press release announcing its collaboration with Daiichi Sankyo for the development and commercialization of trastuzumab deruxtecan, an investigational therapy currently being evaluated for the treatment of multiple HER2-expressing cancers, including those with HER2-low expression. AstraZeneca has agreed to pay $1.35 billion as an up-front payment and an additional $5.55 billion in contingent payments in return for the global development and commercialization rights for trastuzumab deruxtecan (except in Japan). The companies expect to file a regulatory application for trastuzumab deruxtecan in HER2-positive advanced breast cancer indications in the second half of 2019. AstraZeneca expects this deal to be accretive to its EPS starting in 2020.
On March 28, AstraZeneca issued another press release announcing equity dilution to raise $3.5 billion, partly to fund the collaboration with Daiichi Sankyo and partly to repay debt and improve the overall flexibility of its balance sheet.
On May 8, AstraZeneca issued a press release announcing positive top line results from its pivotal Phase 2 DESTINY-Breast01 trial evaluating trastuzumab deruxtecan in the treatment of HER2-positive, unresectable metastatic breast cancer patients who have been previously treated with trastuzumab emtansine. These results are significant, as there are very few treatment options available for these patients.
Calquence in hematologic oncology indications
On June 6, AstraZeneca issued a press release announcing positive results from its Phase 3 ELEVATE-TN trial, which demonstrated improvement in PFS (progression-free survival) in first-line CLL (chronic lymphocytic leukemia) patients treated with Calquence compared to patients on a regimen of chemotherapy and obinutuzumab.
On May 7, the company issued a press release announcing a statistically significant improvement in PFS in its Phase 3 ASCEND trial for Calquence in relapsed/refractory CLL indications compared to rituximab and idelalisib or rituximab and bendamustine regimens. Because of the robust interim results, the trial was stopped earlier than the scheduled timeline.
Already approved in mantle cell lymphoma indications, Calquence is also being studied in combination with Gazyva and Venclexta in first-line CLL indications. The company is also being studied in comparison with the standard of care, Imbruvica, in relapsed/refractory CLL indications.