The pharma company has lately announced several encouraging results from its ongoing clinical trials in lung cancer, gastric cancer, colorectal cancer and liver cancer.
The Phase III ADAURA trial showed for example that treatment with Tagrisso after surgery with curative intent reduced the risk of disease recurrence or death by c. 80%.
“The momentous results of the Phase III ADAURA trial for Tagrisso demonstrate for the first time in a global trial that an EGFR inhibitor can change the course of early-stage EGFR-mutated lung cancer and provide hope for a cure. We are discussing these outstanding data with regulatory authorities and look forward to bringing the benefits of Tagrisso to patients with early-stage disease,” says José Baselga, Executive Vice President, Oncology R&D, AstraZeneca.
In April 2020, an Independent Data Monitoring Committee recommended for the Phase III ADAURA trial to be unblinded two years early based on its determination of overwhelming efficacy. At the time of data cut-off, overall survival (OS) data favored Tagrisso, but were not mature. The trial will continue to assess OS as a secondary endpoint, states AstraZeneca.
In addition, AstraZeneca’s Imfinzi has showed a sustained overall survival benefit in 1st-line extensive-stage small cell lung cancer in the Phase III CASPIAN trial. More than 10% of patients on Imfinzi plus chemotherapy had not progressed and remained on treatment at two years vs. 2.9% on chemotherapy alone.
“After two years median follow-up, Imfinzi continues to show sustained and meaningful improvements in survival and prolonged treatment response for patients facing this devastating and aggressive disease. These data reinforce Imfinzi plus chemotherapy as an important new standard of care for extensive-stage small cell lung cancer patients, and this regimen offers patients convenient dosing every four weeks during maintenance. We look forward to bringing the benefits of Imfinzi to patients around the world,” says Baselga.
Also, the second experimental arm in the CASPIAN trial testing tremelimumab, an anti-CTLA4 monoclonal antibody, added to Imfinzi and chemotherapy showed a trend towards OS, but did not reach statistical significance compared to chemotherapy alone.
In addition, Imfinzi plus tremelimumab have demonstrated promising clinical activity and tolerability in patients with advanced liver cancer, states the company. Results from the global Phase II Study 22 trial testing AstraZeneca’s tremelimumab, an anti-CTLA4 antibody, added to Imfinzi (durvalumab) demonstrated promising clinical activity and tolerability in patients with advanced hepatocellular carcinoma (HCC).
“Based on these compelling results, we see the potential for a single, priming dose of tremelimumab plus Imfinzi to change the treatment landscape and improve outcomes for patients with advanced liver cancer, a setting where new treatments are urgently needed. The Study 22 data are also an encouraging sign for our Phase III HIMALAYA trial testing this regimen in liver cancer, with data expected later this year,” says Baselga.
AstraZeneca has also announced that Enhertu significantly improved tumor response rate and overall survival in HER2-positive metastatic gastric cancer in the Phase II DESTINY-Gastric01 trial. This is the first HER2-directed medicine to show an improvement in overall survival for previously treated metastatic gastric cancer with a 41% reduction in the risk of death vs. chemotherapy. Breakthrough Therapy Designation was recently granted in the US for Enhertu in this setting.
“In DESTINY-Gastric01, the response rate was more than three times higher with Enhertu versus chemotherapy. Additionally, more than half of patients treated with Enhertu were alive at one year compared to less than a third with chemotherapy. In addition to the impressive results we saw in HER2-positive metastatic breast cancer in DESTINY-Breast01, these results in gastric cancer may help further define the role of Enhertu in transforming patient outcomes across multiple HER2-targetable cancers,” says Baselga.
Enhertu also demonstrated meaningful clinical activity in patients with HER2-mutant non-small cell lung cancer in interim analysis of Phase II DESTINY-Lung01 trial. 61.9% of patients with HER2-mutant metastatic non-small cell lung cancer treated with Enhertu achieved a tumour response. Breakthrough Therapy Designation was recently granted in the US for Enhertu in this setting.
“The results seen with Enhertu in patients with metastatic HER2-mutant non-small cell lung cancer are very exciting and highlight the role Enhertu may have as a new treatment option for patients facing a devastating prognosis. Further, the results demonstrate the potential of Enhertu to treat another tumour type among patients with extremely high unmet need,” says Baselga.
Enhertu also achieved a tumor response rate of 45.3% in patients with HER2-positive metastatic colorectal cancer in Phase II DESTINY-CRC01 trial
“These clinically meaningful and durable responses in patients with advanced HER2-positive colorectal cancer support our belief that HER2 is an important treatment target in this disease. Enhertu has now demonstrated impressive clinical activity in four different cancer settings, reinforcing the potential of this remarkable medicine to transform patient outcomes across a range of HER2-targetable tumors,” says Baselga.
Photo: AstraZeneca research