BRAF Inhibitors in Metastatic disease. Grant McArthur MB BS PhD Peter MacCallum Cancer Centre Melbourne, Australia
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1 Inhibitors in Metastatic disease Grant McArthur MB BS PhD Peter MacCallum Cancer Centre Melbourne, Australia
2 Disclosures Research Support Pfizer & Cellgene Consultant Provectus
3 Mortality from Melanoma Source of data Australian Institute of Health and Welfare (AIHW) ACIM (Australian Cancer Incidence and Mortality) Books. AIHW: Canberra and SEER Cancer Statistics Review, (Vintage 2009 Populations), National Cancer Institute. Bethesda, MD,
4 Talk Overview Targeting the -pathway Signaling by and MEK Clinical Efficacy of Inhibiting the /MEK pathway Toxicity of Inhibiting the /MEK pathway
5 Talk Overview Targeting the -pathway Signaling by and MEK Clinical Efficacy of Inhibiting the /MEK pathway Toxicity of Inhibiting the /MEK pathway
6 Oncogenes are Frequently Activated in Melanoma Vemurafenib Dabrafenib Trametinib C. Meldrum, C.Hewitt A. Dobrovic, B. Devitt, R. Salemi, S. W ong, V. Mar
7 Talk Overview Targeting the -pathway Signaling by and MEK Clinical Efficacy of Inhibiting the /MEK pathway Toxicity of Inhibiting the /MEK pathway
8 Normal Cells Melanoma Cells V600E CRAF Proliferation Survival Proliferation Survival
9 The RAS/RAF/MEK/ERK Pathway RAS V600E Dabrafenib Vemurafenib Encorafenib MEK Trametinib Cobimetinib Binimetnib ERK SCH772984
10 Talk Overview Targeting the -pathway Signaling by and MEK Clinical Efficacy of Inhibiting the /MEK pathway Toxicity of Inhibiting the /MEK pathway
11 Phase III BRIM3 Study design Screening V600E mutation Stratification Stage ECOG PS (0 vs 1) LDH level ( vs nl) Geographic region Randomization N=675 Vemurafenib 960 mg po bid (N=337) Dacarbazine 1000 mg/m 2 iv q3w (N=338) Chapman, NEJM, 2011
12 Updated Overall Survival Data BRIM3 Study Flaherty McArthur et et al, al, NEJM. Lancet 2010 Oncology, 2014
13 Updated Progression Free Survival BRIM3 Study Flaherty McArthur et et al, al, NEJM. Lancet 2010 Oncology, 2014
14 Survival- Phase 1 PLX06/02 Study; Vemurafenib Flaherty Kim et al, et Society al, NEJM. of Melanoma 2010 Research, 2012
15 BREAK-3 study design: Dabrafenib Screened N = 733 Dabrafenib 150 mg twice daily n = 187 Enrolled n = 250 3:1 randomization dabrafenib (150 mg po bid) or DTIC (1000 mg/m 2, IV, q3w). DTIC 1000 mg/m 2 IV every 3 weeks n = 63 Dabrafenib 150 mg twice daily n = Adapted from Hauschild, ASCO, 2013
16 Primary endpoint: PFS Investigator- Assessed (June 2012) Proportion Alive Without Progression Number at risk DTIC: median PFS 2.7 months Hazard ratio 0.37 (95% CI: ); P < Dabrafenib: median PFS 6.9 months Time from Randomization (Months) On randomized study treatment at cut-off: dabrafenib 38%, DTIC 8% Median follow-up time: dabrafenib 10.5 months, and DTIC 9.9 months Median PFS following crossover was 4.4 months (n=35; 95% CI: 4.1, 6.3) 16 Hauschild, ASCO, 2013
17 METRIC: Phase III Melanoma Study mutation status Screened (N=1059) V600E/K mutation (n=322) Using allele-specific PCR at RGI Stratification factors LDH (> ULN vs. < ULN) and Prior chemotherapy (Yes vs. No) Populations Trametinib 2mg QD (n=214) FSFV: Dec 2010, LSFV: July 2011 PFS Chemotherapy (n=108) Trametinib 2mg QD Cross-over* ITT (all randomized patients) n=322; Primary efficacy (subset of ITT) n=273 Primary endpoint Progression-Free Survival (PFS) in V600E positive melanoma Secondary endpoints PFS in ITT Overall Survival, Response rate and Safety Chemotherapy = DTIC or paclitaxel *Allowed after independent confirmation of progression Robert, ASCO, 2013
18 Progression Free Survival METRIC Study Flaherty et al, NEJM. NEJM,
19 Overall Survival METRIC Study Flaherty et al, NEJM. 2010
20 Progression Free Survival is a Surrogate for Overall Survival Flaherty Schahendorf et al, et NEJM. al, Lancet 2010 Oncology, 2014
21 BRIM3: Progression-free survival by baseline characteristic (February 01, 2012 cut-off) censored at crossover Factor All patients 675 Age: Sex: ECOG status: 0 1 <65 years 65 years Female Male Disease stage: IIIc M1a M1b M1c LDH: Normal Elevated Number of patients Favors vemurafenib Favors dacarbazine Chapman, ASCO, Hazard ratio and 95% confidence interval 20
22 Progression Free Survival METRIC Study Flaherty et al, NEJM. NEJM,
23 BRIM3: Overall survival by baseline characteristic (February 01, 2012 cut-off) censored at crossover Factor Number of patients Favors vemurafenib Favors dacarbazine All patients 675 Age: Sex: ECOG status: 0 1 <65 years 65 years Female Male Disease stage: IIIc M1a M1b M1c LDH: Normal Elevated Chapman, ASCO, Hazard ratio and 95% confidence interval 20
24 Updated Overall Survival Data BRIM3 Study Flaherty McArthur et et al, al, NEJM. Lancet 2010 Oncology, 2014
25 Talk Overview Targeting the -pathway Signaling by and MEK Clinical Efficacy of Inhibiting the /MEK pathway Toxicity of Inhibiting the /MEK pathway
26 Selected adverse events (% of patients) Vemurafenib Median length of time on vemurafenib treatment: 4.2 months Vemurafenib, n=336 Dacarbazine, n=287 Adverse events All Grade 3 Grade 4 All Grade 3 Grade 4 Arthralgia <1 - Rash Fatigue <1 Photosensitivity LFTs 22 8 <1 5* 1* -* Cutaneous SCC <1 <1 - Keratoacanthoma Skin papilloma 21 < Nausea Neutropenia <1 - < Uveitis** 3 < Discontinuations due to AE: 7% vemurafenib; 4% dacarbazine Adapted from McArthur, ESMO, 2011
27 Photosensitivity 33% in phase III Dummer et al. N Engl J Med. 2012;366: Slide courtesy of Caroline Robert
28 Treatment-Related AEs in 10% of Dabrafenib Patients (June 2012) Dabrafenib n (%) DTIC n (%) AE All Grade 3 Grade 4 All Grade 3 Grade 4 Hyperkeratosis 67 (36) 2 (1) 1 (<1) 1 (2) 0 0 Alopecia 50 (27) 1 (<1) 0 2 (3) 0 0 Skin Skin papilloma 42 (22) Palmar-plantar hyperkeratosis 36 (19) 4 (2) 0 1 (2) 0 0 Rash 56 (30) SCC/KA 18 (10) 14 (7) Gastrointestinal Nausea 26 (14) (39) 0 0 Arthralgia 36 (19) 2 (1) Fatigue 33 (18) 2 (1) 0 13 (22) 0 0 Other Headache 34 (18) (3) 0 0 Pyrexia 30 (16) 5 (3) Asthenia 27 (14) (12) 0 0 Photosensitivity: dabrafenib 4 (2%), DTIC 2 (4%) KA, keratoacanthoma; SCC, sqamous cell carcinoma 28
29 Principles of Managing Dabrafenib Induced Fever Exclude infection Prompt witholding of drugs at first signs of fever/prodrome Paracetamol/acetaminophen/NSAID Steroids 15mg prednislone in refractory cases Dose reduction only for hypotension /dehydration
30 V600E V600E CRAF CRAF inhibitor inhibitor Proliferation Survival Proliferation Survival Proliferation Survival Proliferation Survival
31 METRIC Adverse Events (>15% of patients) Preferred Term (>15% of subjects) Trametinib n=211 Chemotherapy n=99 Rash 121 (57%) 10 (10%) Diarrhoea 91 (43%) 16 (16%) Oedema peripheral 54 (26%) 3 (3%) Fatigue 54 (26%) 27 (27%) Dermatitis acneiform 40 (19%) 1 (1%) Nausea 38 (18%) 37 (37%) Alopecia 36 (17%) 19 (19%) Hypertension 32 (15%) 7 (7%) Constipation 30 (14%) 23 (23%) Vomiting 27 (13%) 19 (19%) MEKi known events with Trametinib: Decreased Ejection Fraction / Ventricular dysfunction = 14 (7%) Chorioretinopathy = 1 (<1%) No reported case of cutaneous SCC or hyperproliferative skin lesions Robert, ASCO,
32 V600E V600E V600E inhibitor Trametinib ORR=22% Vemurafenib ORR= 57% Dabfarenib MEK ORR=50% MEK MEK MEKinhibitor Proliferation Survival Proliferation Survival Proliferation Survival Flaherty et al, NEJM, 2012; ; Hauschild et al, Lancet, 2012; McArthur et al, Lancet Oncology, 2014
33 V600E V600E CRAF CRAF inhibitor inhibitor Proliferation Survival Proliferation Survival Proliferation Survival Proliferation Survival
34 V600E V600E CRAF CRAF MEK MEK MEK MEK MEKinhibitor MEKinhibitor Proliferation Survival Proliferation Survival Proliferation Survival Proliferation Survival
35 Chelsee Hewitt Aleks Rynska Victoria Beshay Alex Dobrovic Cliff Meldrum Stephen Fox Jennifer Mooi Clara Gaff Jayesh Desai Ben Tran Acknowledgements Stephen Wong Victoria Mar Alex Dobrovic John Kelly Richard Scolyer Jason Li Aparna Rao Rod Hicks Jason Callahan Jeanette Raleigh Keith Flaherty Paul Chapman Keith Nolop Axel Hauschild Jeff Sosman Kevin Kim Igor Puzanov Antoni Ribas Joe Grippo Gideon Bollag Richard Lee Study Coordinators Patients & their families
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