AstraZeneca upbeat on raft of positive data

(Sharecast News) - AstraZeneca announced on Monday that the 'MELODY' phase 3 trial for 'nirsevimab' met its primary endpoint of a statistically significant reduction in the incidence of medically-attended lower respiratory tract infections (LRTI) caused by respiratory syncytial virus (RSV) compared to placebo in healthy late preterm and term infants during their first RSV season.
The FTSE 100 pharmaceuticals giant said nirsevimab is a long-acting antibody, using its proprietary YTE technology, being developed by itself and Sanofi, with the potential to provide immunity directly to infants and offer immediate protection against RSV.

It said it was the first potential immunisation to show protection against RSV in the general infant population in a phase 3 trial.

Preliminary analysis of the safety profile for nirsevimab was consistent with previous trial data, with no clinically meaningful differences in safety results between the nirsevimab and placebo groups observed.

The company described RSV as a "very common" contagious pathogen that causes seasonal epidemics of LRTI, including bronchiolitis and pneumonia, and was the leading cause of hospitalisations in infants worldwide.

"These ground-breaking results mark a major scientific advancement in our effort to provide protection against respiratory syncytial virus for all infants," said executive vice-president of biopharmaceuticals research and development.

"Nearly all children will contract the virus before age two, leading to nearly 30 million acute lower respiratory tract infections globally each year.

"Nirsevimab has the potential to provide a significant public health benefit as the first respiratory syncytial virus immunisation for the general infant population, and these data bring us one step closer to delivering nirsevimab to infants worldwide."

At the same time, AstraZeneca said 'selumetinib' has been recommended for conditional marketing authorisation in the European Union (EU) for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in paediatric patients with neurofibromatosis type 1 (NF1) aged three years and above.

It described NF1 as a "debilitating genetic condition" affecting 1 in 3,000 individuals worldwide.

In between 30% and 50% of people with NF1, tumours developed on the nerve sheaths, and could cause clinical issues such as disfigurement, motor dysfunction, pain, airway dysfunction, visual impairment, and bladder and bowel dysfunction.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on results from the 'SPRINT Stratum 1' phase 2 trial.

AstraZeneca said the trial showed selumetinib demonstrated an objective response rate of 66% in paediatric patients with NF1 PN when treated with selumetinib as twice-daily oral monotherapy.

"This recommendation means patients in the EU are one step closer to receiving the only approved medicine for neurofibromatosis type 1 and the only treatment outside of surgery, which is not an option for many patients," said Dave Fredrickson, executive vice-president of the oncology business unit.

"Children living with this rare genetic condition are in great need of novel treatment options to help address the impact of this disease."

Finally, the company said 'Tagrisso', or osimertinib, was recommended for marketing authorisation in the EU for the adjuvant treatment of adult patients with early-stage epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC), after complete tumour resection with curative intent.

The CHMP based its positive opinion on results from the 'ADAURA' phase 3 trial, in which Tagrisso demonstrated a statistically significant and clinically meaningful improvement in disease-free survival in the primary analysis population of patients with stage 2 and 3a EGFRm NSCLC, and in the overall trial population of patients with stage 1b to 3a of the disease.

While up to 30% of all patients with NSCLC might be diagnosed early enough to have surgery with curative intent, recurrence was still said to be common in early-stage disease.

Historically, nearly half of patients diagnosed in stage 1b, and over three quarters of patients diagnosed in Stage 3a, experienced recurrence within five years.

"With no targeted treatment options currently available for early-stage lung cancer patients after surgery in the EU, recurrence rates remain unacceptably high," said Dave Fredrickson.

"This positive recommendation is a vital step towards introducing a targeted treatment option for these patients for the first time.

"It also reinforces the urgency to test all lung cancer patients for tumour mutations before making any treatment decisions to ensure that as many patients as possible can benefit from innovative therapies, like Tagrisso, when they become available."

At 0845 BST, shares in AstraZeneca were up 0.45% at 7,598p.