Combination therapy reduced risk of lung cancer progression by 38%

Non-small cell lung cancer

The US Food and Drug Administration (FDA) has approved AstraZeneca’s osimertinib (Tagrisso) as a treatment for locally advanced or metastatic non-small cell lung cancer (la/mNSCLC).

It is approved in combination with platinum-based chemotherapy for patients with la/mNSCLC whose tumours have EGFR exon 19 deletions or exon 21 L858R mutations.

Efficacy was evaluated in the Phase III trial FLAURA2 in 557 patients with EGFR exon 19 deletion or exon 21 L858R mutation-positive la/mNSCLC and no prior systemic therapy for advanced disease.

Osimertinib plus platinum-based chemotherapy demonstrated a statistically significant improvement in progression-free survival (PFS) compared to osimertinib monotherapy with a hazard ratio of 0.62. The median PFS was 25.5 months and 16.7 months in the respective arms.

While overall survival (OS) results were immature at the current analysis, with 45% of pre-specified deaths for the final analysis reported, no trend towards a detriment was observed.

Pasi Jänne, Medical Oncologist at Dana-Farber Cancer Institute and principal investigator for the trial, said: “This approval based on the unprecedented data from FLAURA2 brings a critical new treatment option to patients with advanced EGFR-mutated non-small cell lung cancer. Now, with the choice of two highly effective osimertinib-based options, physicians can better tailor treatment to an individual’s needs and help ensure the best possible outcome for each patient.”

The FDA review was conducted under Project Orbis, which provides a framework for concurrent submission and review of oncology drugs among international partners. For this review, the FDA collaborated with the Australian Therapeutic Goods Administration (TGA), Health Canada, and Switzerland’s Swissmedic.

Other indications for Tagrisso

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: “This important new treatment option can delay disease progression by nearly nine additional months, establishing a new benchmark with the longest reported progression-free survival benefit in the first-line advanced setting. This news is especially important for those with a poorer prognosis, including patients whose cancer has spread to the brain and those with L858R mutations.”

Tagrisso is approved as monotherapy in more than 100 countries including in the US, EU, China and Japan. Approved indications include for first-line treatment of patients with locally advanced or metastatic EGFRm NSCLC, locally advanced or metastatic EGFR T790M mutation-positive NSCLC, and adjuvant treatment of early-stage EGFRm NSCLC.

The drug is also being investigated in the neoadjuvant setting in the NeoADAURA Phase III trial with results expected later this year, and in the early-stage adjuvant resectable setting in the ADAURA2 Phase III trial.

By DIANA SPENCER, Senior Digital Content Editor, DDW

Related Articles

Join FREE today and become a member
of Drug Discovery World

Membership includes:

  • Full access to the website including free and gated premium content in news, articles, business, regulatory, cancer research, intelligence and more.
  • Unlimited App access: current and archived digital issues of DDW magazine with search functionality, special in App only content and links to the latest industry news and information.
  • Weekly e-newsletter, a round-up of the most interesting and pertinent industry news and developments.
  • Whitepapers, eBooks and information from trusted third parties.
Join For Free