Market Overview

TAGRISSO Is the Only 1st-line Treatment for EGFR-Mutated Non-Small Cell Lung Cancer to Deliver a Median Overall Survival of More Than Three Years

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28% of patients in the global FLAURA trial were still receiving TAGRISSO at three years vs. 9% on either gefitinib or erlotinib

TAGRISSO showed a 52% reduction in risk of central nervous system disease progression or death

AstraZeneca today presented detailed overall survival (OS) results from the Phase III FLAURA trial of TAGRISSO® (osimertinib) in the 1st-line treatment of adult patients with locally-advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC).

Results showed a statistically significant and clinically meaningful improvement in OS, a key secondary endpoint for TAGRISSO versus gefitinib or erlotinib, both of which were previous standard-of-care (SoC) treatments in this setting (HR 0.799 [95% CI, 0.641-0.997], p=0.0462).

TAGRISSO delivered a median OS of 38.6 months versus 31.8 months for the comparator arm. At three years, 28% of patients in the TAGRISSO arm and 9% of patients in the comparator arm remained on 1st-line study treatment. TAGRISSO also showed a statistically significant and clinically meaningful 52% reduction in the risk of central nervous system (CNS) disease progression, increasing the time patients with CNS metastases lived without CNS disease progression or death (HR 0.48 [95% CI, 0.26-0.86], p=0.014).1

The results were presented at the Presidential Symposium of the ESMO (European Society for Medical Oncology) 2019 Congress in Barcelona, Spain (Abstract #LBA5_PR).

José Baselga, Executive Vice President, Oncology R&D said: "TAGRISSO has set a new benchmark in EGFR-mutated non-small cell lung cancer by demonstrating a median overall survival of more than three years. We have not before seen survival benefits of this magnitude in any global Phase III trial with any such therapy. The ground-breaking data reaffirm the benefit of using TAGRISSO first and further support its use as the 1st-line standard of care in this setting."

Dr. Suresh S. Ramalingam, Principal Investigator of the FLAURA trial from Winship Cancer Institute of Emory University, Atlanta, US, said: "The results of the FLAURA trial provide further evidence to support the role of osimertinib as the preferred 1st-line therapy option for patients with EGFR-mutated non-small cell lung cancer. It is highly noteworthy that 28% of patients are still being treated with 1st-line osimertinib at three years versus 9% on either gefitinib or erlotinib."

Summary of FLAURA results

 

TAGRISSO

(n=279)

EGFR-tyrosine kinase

inhibitors (TKI)

(gefitinib or erlotinib)

(n=277)

Progression-free survival (PFS) (primary endpoint)i

 

Median in months

(95% CI)

18.9

(15.2, 21.4)

10.2 months

(9.6, 11.1)

Hazard ratio

(95% CI)

0.46

(0.37, 0.57)

p-value

p < 0.0001

OS (secondary endpoint)i

 

Hazard ratio

(95% CI)

0.799

(0.641-0.997)

p-value

p = 0.0462ii

Median in months

(95% CI)

38.6

(34.5-41.8)

31.8

(26.6-36.0)

Survival at 12 months

(95% CI)

89.1%

(84.8-92.2)

82.5%

(77.4-86.6)

Survival at 24 months

(95% CI)

74.2%

(68.6-79.0)

58.9%

(52.7-64.6)

Survival at 36 months

(95% CI)

53.7%

(47.5-59.5)

44.1%

(38.0-50.1)

CNS PFS (secondary endpoint)I, 1

 

Hazard ratio

(95% CI)

0.48

(0.26-0.86)

p-value

p = 0.014

Median in months

(95% CI)

Not reached

(16.5-NC)iii

13.9

(8.3-NC)iii

Time to first subsequent therapy or death (TFST) (exploratory endpoint)i

 

Hazard ratio

(95% CI)

0.48

(0.39-0.58)

Number (%) of patients with events

69.5%

87.4%

Median in months

(95% CI)

25.5

(22.0, 29.1)

13.7

(12.3, 15.7)

Time to second subsequent therapy or death (TSST) (exploratory endpoint)i

 

Hazard ratio

(95% CI)

0.69

(0.56-0.84)

Number (%) of patients with events

64.5%

73.3%

Median in months

(95% CI)

31.1

(28.8, 35.9)

23.4

(20.0, 25.6)

Patients remaining on initial study treatment

 

12 months

69.5%

47.3%

24 months

42.3%

16.2%

36 months

28.0%

9.4%

I The data cut-off date was 25 June 2019 (OS, TFST, TSST) and 12 June 2017 (PFS, CNS PFS)

ii Criteria for statistical significance at the final analysis of OS was a p-value of less than 0.0495 (determined by O'Brien- Fleming approach)

iii NC=Not Calculable

In the FLAURA trial, the safety and tolerability of TAGRISSO was consistent with its established profile. TAGRISSO was generally well tolerated, with Grade 3 or higher adverse events (AEs) occurring in 42% of patients taking TAGRISSO versus 47% in the comparator arm. The most common AEs in patients treated with TAGRISSO were diarrhea (60%), rash (59%), nail toxicity (39%), dry skin (38%), stomatitis (29%), fatigue (21%) and decreased appetite (20%). Despite almost twice the length of therapy, fewer patients experienced a grade 3 or higher AE (42% vs. 47%) or discontinued due to AEs (15% vs. 18%).

The FLAURA trial met its primary endpoint in July 2017, showing a statistically significant and clinically meaningful improvement in PFS, increasing the time patients lived without disease progression or death from any cause.

TAGRISSO is currently approved in 78 countries, including the US, Japan, China and the EU, for 1st-line EGFR-mutated (EGFRm) metastatic NSCLC.

TAGRISSO IMPORTANT SAFETY INFORMATION

TAGRISSO may cause serious side effects, including:

  • lung problems. TAGRISSO may cause lung problems that may lead to death. Symptoms may be similar to symptoms from lung cancer. Tell your doctor right away if you have any new or worsening lung symptoms, including trouble breathing, shortness of breath, cough, or fever
  • heart problems, including heart failure. TAGRISSO may cause heart problems that may lead to death. Your doctor should check your heart function before you start taking TAGRISSO and during treatment as needed. Tell your doctor right away if you have any of the following signs and symptoms of a heart problem: feeling like your heart is pounding or racing, shortness of breath, swelling of your ankles and feet, feeling lightheaded
  • eye problems. TAGRISSO may cause eye problems. Tell your doctor right away if you have symptoms of eye problems which may include watery eyes, sensitivity to light, eye pain, eye redness, or vision changes. Your doctor may send you to see an eye specialist (ophthalmologist) if you get eye problems with TAGRISSO

Before taking TAGRISSO, tell your doctor about all of your medical conditions, including if you:

  • have lung or breathing problems
  • have heart problems, including a condition called long QTc syndrome
  • have problems with your electrolytes, such as sodium, potassium, calcium or magnesium
  • have a history of eye problems
  • are pregnant or plan to become pregnant. TAGRISSO can harm your unborn baby. Tell your doctor right away if you become pregnant during treatment with TAGRISSO or think you may be pregnant
  • Females who are able to become pregnant should use effective birth control during treatment with TAGRISSO and for 6 weeks after the final dose of TAGRISSO
  • Males who have female partners that are able to become pregnant should use effective birth control during treatment with TAGRISSO and for 4 months after the final dose of TAGRISSO
  • are breastfeeding or plan to breastfeed. It is not known if TAGRISSO passes into your breast milk. Do not breastfeed during treatment with TAGRISSO and for 2 weeks after your final dose of TAGRISSO. Talk to your doctor about the best way to feed your baby during this time

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, or herbal supplements. Especially tell your doctor if you take a heart or blood pressure medicine

The most common side effects of TAGRISSO are:

  • diarrhea
  • rash
  • dry skin
  • changes in your nails, including: redness, tenderness, pain, inflammation, brittleness, separation from nailbed, and shedding of nails
  • mouth sores
  • tiredness
  • decreased appetite

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of TAGRISSO. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is TAGRISSO?

TAGRISSO is a prescription medicine for non-small cell lung cancer (NSCLC) that has spread to other parts of the body (metastatic). TAGRISSO is used:

  • as a first treatment if tumors have a certain abnormal epidermal growth factor receptor (EGFR) gene(s)

or

  • for a certain type of EGFR gene that has been treated with a
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