Molecular diagnostic

services for solid

tumours

Association for Clinical Genetic Science Summer Scientific Meeting

5th July 2016

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• 5 core-funded institutes

• 15 Centres

• 4 Cancer Imaging Centres

• 18 Experimental Cancer Medicine Centres (ECMCs)

• 7 Clinical Trials Units

+ CRUK Centre for Drug Development

+ CRT Discovery Laboratories

The Cancer Research UK Network

Precision medicine

Cancer prevention

Substantially increased investment in:

Early diagnosis research

Cancers of unmet need

Basic understanding

of cancer

Therapeutic innovation

Precision Medicine

TAILORING TREATMENT AND CARE TO INDIVIDUAL PATIENTS BASED ON THE MOLECULAR MAKE-UP OF THEIR DISEASE.

• For cancer this means giving patients the right medicines, targeted to their cancer, at the right time

BENEFITS OF PRECISION MEDICINES:

• Longer progression-free or overall survival

• Avoiding side-effects from ineffective treatments

We have had some success in targeting pathogenetic changes

Druker BJ et al. N Engl J Med 2001;344:1031-1037.

O'Brien SG et al. N Engl J Med 2003;348:994-1004.

Nowell PC & Hungerford DA, J Natl Cancer Inst. 1960 Jul;25:85-109.

Genomic analysis can show which groups of patients will respond better to a drug

Source: Giaccone, G. et al. J Clin Oncol; 22:777-784

2004, Mok T et al. N Engl J Med 2009;361:947-957

Gefitinib no more effective than placebo overall

Gefitinib more effective than standard treatment if EGFR+

Gefitinib less effective than standard treatment if EGFR-

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From Blockbusters to Stratified Medicine. Brighton ICR March 2011

EGFR-mutant lung cancer treated with Gefitinib 7

Precision Medicine

• What the NHS needs to do to make it possible:

– Research environment

– Molecular diagnostics

But in England, diagnostic provision

has lagged behind demand

Patients for whom no testing means less options

2014 survey data

CANCER TASKFORCE STRATEGY:

NHS England should transform access to molecular diagnostics to guide treatment for cancer:

• A nationally commissioned molecular diagnostic service

• Tests should be added to the COSD dataset

• A year by year review of capacity

• Plans to move to a validated molecular diagnostic panel test by end of 2016.

What is needed in England?

Biomarker etc Drug etc

Biomarker A : Drug A

Biomarker B : Drug B

Biomarker C : Drug C

Biomarker D : Drug D

Biomarker E: Drug E

Biomarker F : Drug F

NGS sequencing

• Up to 2000 NSCLC patients screened per year • National screening to national trial • 28 gene multiplexed NGS panel; detects mutations,

deletions, CNV and DNA rearrangement • Utilising DNA from routine FFPE biopsies

• 7 drugs, 20 stratified arms • Phase 2a signal finding study • Rolling protocol, capable of incorporating new arms • Sponsored by CRCTU at Birmingham • PI Professor Gary Middleton • Recruit across 18 ECMC centres

Pre-screening MATRIX Lung Study

• Government and NHS England committed to 25,000 more people receiving molecular diagnostic tests/year

• NHS England developing a personalised medicines strategy.

• National Tariff for 2016/17 now includes specific funding form some molecular diagnostic tests for cancer.

Progress to date…

Precision medicine will play a crucial role in cancer care.

It is vital that the NHS supports the development and application of precision medicines through:

• Molecular diagnostic tests for all eligible patients

• Sustaining the right environment for research

Summary

THANK YOU