Network Experience of TKI inhibitors as 1st line use in advanced NSCLC

Dr Jill Gardiner and Mr Steve WilliamsonApril 2012

Plans for Iressa Audit

Preliminary data only from Astra Zeneca.No information on toxicity and QL.Numbers for each trust are small so all of the region needs to be included in the audit to produce meaningful data.Centralisation of Consent/Caldecott via the Network will allow much easier access of patient information across the region.

Iressa Audit

• Cover period 2010 and 2011• Response rates• Duration of treatment• Toxicity• Response to 2nd line treatment• Overall survival

Tarceva

Tarceva

• A standard second line treatment for Advanced NSCLC in the region.

• Data is now available in the first line setting for mutation positive advanced NSCLC.

• Tarceva has a licence as a first line treatment for mutation positive advanced NSCLC.

• It is at least comparable with the Iressa data.• It has the advantage of Phase 3 data in the

European population – the EURTAC study

Data Summary

RR TKI v chemo PFS TKI v chemo

Asian IressaIPASS ( Mok et al NEJM 361 p947 2009)

71.2% v 47.3% 9.5m v 6.3m

Asian TarcevaOPTIMAL ( Zhou et al Lancet Oncology 12 p 735 2011)

83% v 36% 13.1m v 4.6m

European TarcevaEURTAC ( Rossell et al ASCO 2011 #7503)

58% v 15% 9.4m v 5.2m

Best overall response in ITT population

Erlotinib(n=77)n (%)

Chemotherapy(n=76)n (%)

Erlotinib(n=86)n (%)

Chemotherapy(n=87)n (%)

Complete response 2 (3) 0 (0) 2 (2) 0 (0)

Partial response 40 (52) 8 (11) 48 (56) 13 (15)

Objective response rate 42 (55) 8 (11) 50 (58) 13 (15)

Stable disease 18 (23) 42 (55) 18 (21) 44 (51)

Disease control rate 60 (78) 50 (66) 68 (79) 57 (66)

Progressive disease 6 (8) 10 (13) 6 (7) 11 (13)

No response assessment 11 (14) 16 (21) 12 (14) 19 (22)

Interim analysis(Aug 2, 2010)

Updated analysis(Jan 26, 2011)

Conclusions• EURTAC is the first prospective study of an EGFR tyrosine-kinase inhibitor (TKI)

versus chemotherapy for first-line treatment of EGFR mutation-positive NSCLC in Caucasian patients

• The study results confirms significant benefit in PFS of erlotinib over standard chemotherapy– 63% reduction in risk of progression (HR=0.37)

• OS data are immature, with high level of known crossover

• As expected, no new safety findings– tolerability of erlotinib was consistent with previous studies

• Erlotinib provides significant benefits over first-line chemotherapy in EGFR mutation-positive disease

Tarceva as first line treatment for Mutation positive NSCLC

• Approved by SMC Jan 2012

• Approved by NECDAG Jan 2012

• Due for NICE review June 2012

Tarceva

• Will everyone switch to Tarceva or will some continue to use Iressa?

• The plan is to audit the data we obtain.• May allow us to do a comparison with the

Iressa data.