Download Scottish `yes` - Roy Castle Lung Cancer Foundation

PRESS RELEASE FOR UK
CONSUMER AND
MEDICAL / TRADE MEDIA
EMBARGOED UNTIL
00:01 12 JULY 2016
Scottish ‘yes’ for breakthrough lung cancer treatment
triggers UK survival lottery
(Uxbridge, Middlesex, 12 July 2016) – Bristol-Myers Squibb today announced that the Scottish
Medicines Consortium (SMC), the equivalent of the National Institute for Health and Care
Excellence (NICE) in Scotland, has recommended the breakthrough cancer immunotherapy
Opdivo® (nivolumab) to treat NHS patients with locally advanced or metastatic squamous nonsmall cell lung cancer (NSCLC) whose disease has progressed after prior chemotherapy. While the
news is positive for Scottish patients, the decision could trigger a UK survival lottery. The assessment
of nivolumab by NICE is currently ongoing, meaning that the treatment remains unavailable for NHS
patients living in England; it also remains unavailable in Wales and Northern Ireland. 1 If NICE
upholds its draft guidance not to recommend the use of nivolumab, treatment options for patients
outside of Scotland will continue to be limited to a chemotherapy first approved nearly 20 years
ago. 2,3,4
Nivolumab is the first in a class of medicines (PD-1 immune checkpoint inhibitors) for the treatment
of lung cancer patients. 5 It has an innovative mode of action that works by harnessing the ability of
the immune system to fight this type of advanced lung cancer as well as advanced forms of skin and
kidney cancer.5
“Today’s decision gives Scottish NHS patients the chance to benefit from one of the biggest treatment
advances in this type of lung cancer for decades and one that has the potential to change future
survival expectations.” said Johanna Mercier, General Manager of Bristol-Myers Squibb UK &
Ireland. “While this decision is positive news for lung cancer patients in Scotland, it will further
compound the disappointment of patients in the rest of the UK, who are still waiting for access to this
medicine. This demonstrates how antiquated the current UK system for reviewing new cancer
medicines is and the disparity that it creates for patients and their families. We call on the UK
Government to bring an end to the outdated processes that, in 2016, still mean that a person’s ability
to access a cancer medicine on the NHS is determined not by their needs, but by where they live.”
Job number: 1506UK1601239
Date of preparation: July 2016
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare
professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. Adverse
reactions should also be reported to Bristol-Myers Squibb Medical Information on 0800 731 1736 or [email protected]
In a pivotal Phase III study of 272 patients, treatment in the nivolumab arm (n=135) was shown to
achieve significantly superior survival rates with 42% of patients still alive at one-year compared to
24% of those treated with docetaxel (n=137).4 Severe treatment-related adverse events occurred less
frequently with nivolumab (out of 131 patients treated with nivolumab, 7% had grade 3-4 adverse
events compared to 55% of 129 patients treated with docetaxel).4
The disparity in access to nivolumab focusses on patients with a form of advanced lung cancer, which
continues to be a growing health burden in the UK today. In 2012, over 44,500 people in the UK were
diagnosed with all types of lung cancer. 6 In the same year, over 35,000 deaths were attributable to the
disease6 - more than breast and bowel cancer deaths combined. 7,8 UK survival rates continue to lag
almost a decade behind some other comparable European countries with around 80% of those
diagnosed with advanced disease dying within one year. 9,10
# ENDS #
Job number: 1506UK1601239
Date of preparation: July 2016
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare
professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. Adverse
reactions should also be reported to Bristol-Myers Squibb Medical Information on 0800 731 1736 or [email protected]
NOTES TO EDITORS
Data supporting the use of nivolumab
The data supporting the use of nivolumab in squamous NSCLC is based on a Phase III study
comparing nivolumab to docetaxel, published in The New England Journal of Medicine in May 2015.
This study assessed the efficacy and safety of nivolumab in adult patients with advanced squamous
cell NSCLC whose disease had progressed during or after one prior platinum containing
chemotherapy regimen.4 Treatment with nivolumab (n=135) was shown to achieve significantly
superior survival rates, with 42% (n=135, 95% confidence interval [CI] = 34-50) of patients still alive
at one year compared with 24% (n=137, 95% CI = 17-31) of those treated with docetaxel.4
Severe treatment-related adverse events occurred less frequently with nivolumab (out of the 131
patients treated with nivolumab, 7% had grade 3-4 adverse events compared to 55% of 129 patients
treated with docetaxel).4 The majority of adverse reactions for nivolumab were mild to moderate
(grade 1 or 2).4 Due to nivolumab’s mechanism of action, it causes immune-related adverse reactions,
most of these, including severe reactions, are resolved following initiation of appropriate medical
therapy or withdrawal of nivolumab.5
About nivolumab
In Europe, nivolumab is licensed as monotherapy under the brand name Opdivo® for the treatment
of adult patients with: 5
•
Advanced (unresectable or metastatic) melanoma
•
Locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy
•
Advanced renal cell carcinoma after prior therapy
In addition, nivolumab is licensed in combination with ipilimumab for the treatment of adult patients
with advanced (unresectable or metastatic) melanoma.5
Bristol-Myers Squibb has a broad, global development programme to study nivolumab in multiple
tumour types consisting of more than 50 trials – as monotherapy or in combination with other
therapies – in which more than 8,000 patients have been enrolled worldwide.
Job number: 1506UK1601239
Date of preparation: July 2016
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare
professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. Adverse
reactions should also be reported to Bristol-Myers Squibb Medical Information on 0800 731 1736 or [email protected]
Bristol-Myers Squibb & Immuno-Oncology: Advancing Oncology Research
At Bristol-Myers Squibb, we have a vision for the future of cancer care that is focused on ImmunoOncology, now considered a major treatment choice alongside surgery, radiation, chemotherapy and
targeted therapies for certain types of cancer.
We have a comprehensive clinical portfolio of investigational and approved Immuno-Oncology
agents, many of which were discovered and developed by our scientists. Our ongoing ImmunoOncology clinical programme is looking at broad patient populations across multiple solid tumours
and haematological malignancies, with the intent of powering our trials for overall survival and other
important measures like durability of response.
We pioneered the research leading to the first regulatory approval for the combination of two
Immuno-Oncology agents, and continue to study the role of combinations in cancer.
We are also investigating other immune system pathways in the treatment of cancer including CTLA4, CD-137, KIR, SLAMF7, PD-1, GITR, CSF1R, IDO, and LAG-3. These pathways may lead to
potential new treatment options – in combination or monotherapy – to help patients fight different
types of cancers.
Our collaboration with academia, as well as small and large biotech companies is responsible for
researching the potential Immuno-Oncology and non-Immuno-Oncology combinations, with the goal
of providing new treatment options in clinical practice. At Bristol-Myers Squibb, we are committed to
changing survival expectations in hard-to-treat cancers and the way patients live with cancer.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop
and deliver innovative medicines that help patients prevail over serious diseases. For more
information about Bristol-Myers Squibb, visit www.b-ms.co.uk.
Media contacts
Tim Cockroft
Reynolds-MacKenzie
T: +44 (0)207 861 2805
M: +44 (0)7957 325 583
E: [email protected]
Dominique Jaquest
Bristol-Myers Squibb
Pharmaceuticals Ltd
T: +44 (0)1895 523639
E: [email protected]
Sapna Rughani
Bristol-Myers Squibb
Pharmaceuticals Ltd
T: +44 (0)1895 523233
E: [email protected]
Job number: 1506UK1601239
Date of preparation: July 2016
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare
professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. Adverse
reactions should also be reported to Bristol-Myers Squibb Medical Information on 0800 731 1736 or [email protected]
References
1 National Institute of Health and Care Excellence (NICE). Appraisal Consultation Document (ACD). Nivolumab for previously treated
locally advanced or metastatic squamous non-small cell lung cancer. Available at: https://www.nice.org.uk/guidance/GIDTAG506/documents/appraisal-consultation-document. Last accessed July 2016
2 National Institute of Health and Care Excellence (NICE). Lung cancer diagnosis and management. Available at:
https://www.nice.org.uk/guidance/cg121/chapter/1-Guidance#treatment Last accessed July 2016
3 Docextaxel EPAR. Available at:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000073/human_med_001081.jsp&mid=WC0b01ac05800
1d124. Last accessed July 2016
4 Brahmer, J. et al. Nivolumab versus docetaxel in advanced squamous-cell non-small-cell lung cancer. N Engl J Med 2015. Epub ahead of
print at nejm.org, May 31, 2015. doi: 10.1056/NEJMoa1504627
5 Opdivo Summary of Product Characteristics. Available at: http://www.medicines.org.uk/emc/medicine/30476 Last accessed July 2016
6 Cancer Research UK. Lung Cancer Statistics. Available at: http://www.cancerresearchuk.org/health-professional/cancerstatistics/statistics-by-cancer-type/lung-cancer. Last accessed July 2016.
7 Cancer Research UK. Breast cancer statistics. Available at: http://www.cancerresearchuk.org/health-professional/cancerstatistics/statistics-by-cancer-type/breast-cancer. Last accessed July 2016
8 Cancer Research UK. Bowel cancer statistics. Available at: http://www.cancerresearchuk.org/health-professional/cancerstatistics/statistics-by-cancer-type/bowel-cancer. Last accessed July 2016
9 Claudia Allemani et al. Global surveillance of cancer survival 1995–2009: analysis of individual data for 25 676 887 patients from 279
population-based registries in 67 countries (CONCORD-2). Lancet 2015; 385:977-1010
10 Cancer Research UK. Lung cancer (C33-C34): 2012. One-Year Relative Survival (%) by Stage, Adults Aged 15-99, England. Available
at: http://www.cancerresearchuk.org/sites/default/files/cstream-node/surv_1yr_lung_0.pdf Last accessed July 2016
Job number: 1506UK1601239
Date of preparation: July 2016
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare
professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. Adverse
reactions should also be reported to Bristol-Myers Squibb Medical Information on 0800 731 1736 or [email protected]