Three AstraZeneca drugs recommended for EU approval

AstraZeneca announced on Monday morning that three of its drugs had been recommended for approval in the European Union.

The FTSE 100 pharmaceuticals giant said ‘Imfinzi’ plus chemotherapy had been recommended for approval as a first immunotherapy regimen for advanced biliary tract cancer, and ‘Enhertu’ had been recommended for patients with previously-treated HER2-positive advanced gastric cancer.

‘Lynparza’, in combination with abiraterone, was meanwhile recommended for approval as a first-line treatment for patients with metastatic castration-resistant prostate cancer.

The company said the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) based its positive opinion on Lynparza on results from the ‘PROpel’ phase 3 trial, published in NEJM Evidence in June.

In the trial, Lynparza, in combination with abiraterone and prednisone or prednisolone, reduced the risk of disease progression or death by 34% versus abiraterone alone.

Median radiographic progression-free survival was 24.8 months for Lynparza plus abiraterone, versus 16.6 months for abiraterone alone.

The results also showed that Lynparza in combination with abiraterone extended median radiographic progression-free survival by almost one year, with a median of 27.6 months versus 16.4 with abiraterone alone, as assessed by blinded independent central review.

Updated results also showed a “favourable trend” in improved overall survival with Lynparza plus abiraterone, versus abiraterone alone, however the difference did not reach statistical significance at the time of the data cut-off.

“With the incidence and mortality of prostate cancer set to double in the coming decades, it is more important than ever that we bring new treatment options to suitable patients at the earliest possible moment in their care,” said AstraZeneca’s executive vice-president of oncology research and development, Susan Galbraith.

“If approved, Lynparza in combination with abiraterone and prednisone or prednisolone will represent the first combination of a PARP inhibitor and new hormonal agent available to patients in the European Union.”

The CHMP meanwhile based its positive opinion on Imfinzi on the primary results from the ‘TOPAZ-1’ phase 3 trial published in the New England Journal of Medicine Evidence, and on the updated results presented at the European Society for Medical Oncology Congress 2022.

At the interim analysis, Imfinzi plus chemotherapy reduced the risk of death by 20% versus chemotherapy alone,

Updated results from TOPAZ-1, after an additional 6.5 months of follow-up, showed a 24% reduction in the risk of death versus chemotherapy alone, with more than two times as many patients estimated to be alive at two years versus chemotherapy alone,

AstraZeneca said updated median overall survival was 12.9 months versus 11.3 with chemotherapy.

“If approved, Imfinzi plus chemotherapy will provide patients with advanced biliary tract cancer the first opportunity for treatment with an immunotherapy-based combination,” Susan Galbraith said.

“This innovative regimen has been shown to significantly prolong patients' lives, and we look forward to bringing this option to those in the European Union as soon as possible.”

Finally, the company said the CHMP based its positive opinion on Enhertu on results from the ‘DESTINY-Gastric02’ and ‘DESTINY-Gastric01’ phase 2 trials.

In DESTINY-Gastric02, conducted in patients from North America and Europe, updated results showed treatment with Enhertu resulted in a confirmed objective response rate of 41.8% as assessed by independent central review.

The median duration of response was 8.1 months, and median overall survival was 12.1 months.

In DESTINY-Gastric01, conducted in patients from Japan and South Korea, updated results meanwhile showed treatment with Enhertu resulted in an objective response rate of 51.3%, versus 14.3% with chemotherapy.

Patients treated with Enhertu had a 40% reduction in the risk of death versus patients treated with chemotherapy, with a median overall survival of 12.5 months versus 8.9 months.

Additionally, the confirmed objective response rate - a “major efficacy outcome” - was 42.0% with Enhertu versus 12.5% with chemotherapy as assessed by independent central review.

“Gastric cancer is usually diagnosed in the advanced stage in many European countries and patients face high mortality rates,” Susan Galbraith added.

“If approved, Enhertu would be the first HER2-directed medicine for patients with advanced gastric cancer in the European Union in more than a decade.”

Reporting by Josh White for Sharecast.com.