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02-Jan-2019

UK patients with a form of advanced lung cancer granted early access to Roche’s immunotherapy Tecentriq ®â–¼ (atezolizumab) by regulators 

Thursday 27 December, 2018, Welwyn Garden City – From today, UK patients with a form of advanced lung cancer can access the immunotherapy, Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab), carboplatin and paclitaxel (chemotherapy), following a positive scientific opinion by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), under the Early Access to Medicines Scheme (EAMS).[i]

This combination treatment will be available to adult patients with metastatic non-squamous non-small cell lung cancer (NSCLC) with EGFR activating or ALK positive tumour mutations after failure of appropriate targeted therapies, under the terms of the EAMS agreement.1

The goal of EAMS is to provide early availability for innovative unlicensed medicines to UK patients that have a high degree of unmet clinical need prior to Marketing Authorisation.[ii]  Medicines in the scheme include those that are intended to treat, diagnose or prevent seriously debilitating or life-threatening conditions where there are no adequate treatment options or existing treatment options have serious limitations.2

Simon Eayrs, Cancer Immunotherapy Lead, Roche Products UK said: “We are delighted with the MHRA’s positive scientific opinion in this area of high unmet need.  This decision supports our combination approach for Tecentriq in lung cancer and is a best practice example of how we can work together with healthcare bodies to deliver access to innovative medicines faster.” 

The MHRA’s decision is based on results from a subgroup of patients in the Phase III IMpower150 study, who have EGFR activating/ALK positive tumour mutations and previously failed on targeted therapies.

 

RXUKCOMM01988

December 2018

 

ENDS

FURTHER INFORMATION:

Adverse reaction reporting

â–¼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme: website www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Lung Cancer: Fast Facts

  • About 87% of lung cancers in the UK are non-small-cell lung cancer (NSCLC).[iii]
  • Over 46,000 new cases of lung cancer are diagnosed in the UK each year, with over 35,800 deaths annually.[iv]
  • The prognosis for lung cancer patients is often poor, with fewer than 5% of all lung cancer patients surviving for ten years, experiencing high rates of recurrence and treatment resistance.[v],[vi]

About IMpower150

IMpower150 is a multi-centre, open-label, randomized (N=1225), controlled Phase III study evaluating the efficacy and safety of atezolizumab in combination with chemotherapy (carboplatin and paclitaxel) with or without bevacizumab in people with metastatic non-squamous NSCLC who had not previously been treated with chemotherapy (first-line). The study enrolled 1,202 people, of whom 157 were people with EGFR activating/ALK positive tumour mutations who had progressed on or been intolerant to previous TKI therapy.1

People were split into three arms:

  • Arm A: Tecentriq plus carboplatin and paclitaxel
  • Arm B: Tecentriq and Avastin plus carboplatin and paclitaxel
  • Arm C: Avastin plus carboplatin and paclitaxel

The co-primary endpoints of OS and PFS in the intent-to-treat wild type (ITT-WT) were positive for this study.[vii] The median PFS was 8.3 months in the patients treated with ABCP compared to 6.8 months in patients treated with BCP alone (HR: 0.62 (95% CI, 0.52-0.74), p=<0.001).8 The median OS among patients treated with ABCP was 19.2 months compared with 14.7 months for people treated with BCP alone (HR: 0.78 (95% CI 0.64-0.96),p=0.02).8

The distribution across the treatment arms for the EGFR activating/ALK positive tumour mutations patient subgroup was as follows1:

  • Arm A: 53 patients
  • Arm B: 41 patients
  • Arm C: 63 patients

The IMpower150 study showed patients with EGFR activating/ALK positive tumour treated with

ABCP achieved a median PFS of 10.0 months vs 6.1 months in patients treated with BCP alone (HR=0.55; 95% CI 0.34-0.90; p=0.0167).1 For this subgroup, treatment with ABCP also resulted in OS compared with BCP alone.[viii]  Median OS in patients treated with ABCP was not reached (95% CI 17.0, NE), compared to 17.5 months in people treated with BCP alone (95% CI 10.4, NE), HR 0.57 (0.29, 1.11), p= 0.093.1

Atezolizumab in combination with carboplatin and paclitaxel with or without bevacizumab was well tolerated, and safety was consistent with the known risks of each study treatment.1

About EAMS

The Early Access to Medicines Scheme (EAMS) is a UK scheme from the MHRA that aims to give patients with life threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation when there is a clear unmet medical need.2 The MHRA will withdraw the EAMS positive scientific opinion when a marketing authorisation for this indication is received.1

About atezolizumab

Atezolizumab is a cancer immunotherapy. It disarms the cancer of its cloak, which allows the body's smartest medicine - the immune system - to detect and destroy it. Atezolizumab blocks PD-L1 – an important ligand found on the surface of cancer cells that camouflage them from detection and destruction by the immune system.[ix] Atezolizumab is also being trialled as a treatment for a range of other cancers, alone and in combination, including: bladder cancer, breast cancer, renal cell carcinoma (kidney cancer), small cell lung cancer, other solid tumours, diffuse large B-cell lymphoma (DLBCL) and paediatric cancers.[x]

Atezolizumab is currently indicated:

  • As monotherapy for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy
  • As monotherapy for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC):
    • after prior platinum‑containing chemotherapy, or
    • who are considered cisplatin ineligible, and whose tumours have a PD-L1 expression ≥5%

About Roche

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases and neuroscience. Roche is also the world leader in in-vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostics that enable tangible improvements in the health, quality of life, safety and survival of patients. Thirty medicines developed by Roche are included in the WHO Model Lists of Essential Medicines, among them life-saving antibiotics and chemotherapy.  Roche in the UK employs over 2,000 people in pharmaceuticals and diagnostics. For more information: www.roche.co.uk

All trademarks used or mentioned in this release are protected by law.

 

References

[i] EAMS 00031/005 Atezolizumab, bevacizumab + carboplatin + paclitaxel HCP treatment protocol (approved December 2018)

[ii] Gov UK. (2016) Apply for the early access to medicines scheme (EAMS). Available at: https://www.gov.uk/guidance/apply-for-the-early-access-to-medicines-scheme-eams. [Last accessed December 2018]

[iii] Cancer Research UK. Lung cancer stages, types and grades. Available at: www.cancerresearchuk.org/about-cancer/lung-cancer/stages-types-grades/types [Last accessed: December 2018]

[iv] Cancer Research UK. Lung Cancer Statistics. Available at: http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/lung-cancer#heading-One [Last accessed: December 2018]

[v] Tsvetkova and Goss. Drug resistance and its significance for treatment decisions in non-small-cell lung cancer. Curr Oncology. 2012;19(Suppl 1):S45–S51.

[vi] Froudarakis, M., and Briasoulis, E. (2010). Advanced non-small cell lung cancer: on relapse rechallenge the tumor, not the patient. BioMed Central Research Notes. 3, 195. Available at: www.ncbi.nlm.nih.gov/pmc/articles/PMC2914654/ [Last accessed: December 2018]

[vii] Socinski MA et al. N Engl J Med; 378 (June 2018) 2288-2301

[viii] Socinski MA et al. Journal of Clinical Oncology 36, no.15 suppl (May 2018) 9002-9002.

[ix] National Cancer Institute (2016) Definition of atezolizumab. NCI Drug Dictionary. [online] Available at: https://www.cancer.gov/publications/dictionaries/cancer-drug?CdrID=702758 [Last accessed: December 2018]

[x] Roche Data on File: RXUKCOMM01580a

Editor Details

  • Company:
    • Virgo Health
  • Name:
    • Francesca Morley
Last Updated: 02-Jan-2019