Second - Line Debate: Axitinib

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2 Second - Line Debate: Axitinib Alain Ravaud, MD PhD Bordeaux, France

3 DISCLOSURES Member of Global, European and/or French advisory board in RCC and/or GU tumors for Pfizer, Novartis, GSK, Roche, BMS, Merck. Institutional Grant support by Pfizer, Novartis Transportation and housing for meeting and speeches by Pfizer, Novartis, GSK, BMS

4 CONTEXT OF POSITIONNING All 4 drugs are available You know how to use it: so trust reported efficacy, frequency and severity of side effects, % of stopping drug due to AE, average dosage in long term exposure. Far from the excitation of new, up to date in 2016 To only a scientific approach

5 QUESTIONS TO ANSWER DOES ANGIOGENESIS/VEGF A MAJOR PATHWAY IN NATURAL HISTORY IN MRCC OVERTIME : THE ANSWER IS YES DOES ANY REASON TO SPEED FOR A CHANGE IN THE MODE OF ACTION OF DRUGS : THE ANSWER IS NO DOES AXITINIB HAS ANY IMPACT ON OVERALL SURVIVAL : THE ANSWER IS YES DOES AXITINIB HAS THE FAIREST THERAPEUTIC INDEX IN THE CHOICE OF VEGFR DRIVEN INHIBITORS : THE ANSWER IS YES DOES OUTSIDE TO BE JUST NEW AND UP TO DATE IN 2016 AXITINIB REPRESENTS THE FAIREST ALTERNATIVE IN SECOND LINE FOR THE MAJORITY OF PATIENTS : THE ANSWER IS YES

6 CONDUCT OF POSITIONNING VEGF TKI (axitinib) vs. nivolumab MRCC is a VEGF driven tumor Early PFS decrease more present in nivolumab vs. axitinib Gain in OS : Comparator everolimus vs. sorafenib Population INTORSECT Axitinib vs. Cabozantinib Gain in OS : idem Dose adaptation in favor of axitinib Therapeutic balance with side effects profile in favor of axitinib

7 CONDUCT OF POSITIONNING VEGF TKI (axitinib) vs. nivolumab MRCC is a VEGF driven tumor Early PFS decrease more present in nivolumab vs. axitinib Gain in OS : Comparator everolimus vs. sorafenib Population INTORSECT Patient information Axitinib vs. Cabozantinib Gain in OS : idem Dose adaptation in favor of axitinib Therapeutic balance with side effects profile in favor of axitinib

8 DOES ANGIOGENESIS/VEGF A MAJOR PATHWAY IN NATURAL HISTORY IN MRCC OVERTIME MRCC is mainly a VEGF driven tumor all along natural history Relationship of mutation of VHL-HIF-VEGF (1,2,3) Preclinical argument of implication of VEGF and impact of inhibition (4) Preclinial argument to consider remaining implication of angiogenesis while progression on on-going VEGF inhibition (5, 6) Clinical evidence of efficacy of second line VEGFR inhibition after progression under 1 st line of VEGFR inhibition (7) Clinical evidence of efficacy of second line VEGFR inhibition after rapid progression (< 3 months) 1 st line of VEGFR inhibition during AXIS trial (7) Clinical evidence of efficacy of rechallenging tumor progression with VEGF inhibition whatever the line of treatment (8) 1. Illiopoulos et al. Nat Med 1995; 2. Rankin et al. Cancer Res 2006; 3. Kondo et al. PLoS Biol 2003; 4. Borgström et al. Cancer Res 1996 ; 5. Zhang L et al. Plos One 2011 ; 6. Bhatt RS et al, Mol Cancer Ther 2010 ; 7, Rini B et al. Lancet 2011 ; 8. Porta C et al. Br J Cancer 2014

9 DOES ANY REASON TO SPEED FOR A CHANGE IN THE MODE OF ACTION OF DRUGS : THE ANSWER IS NO Since years the majority of patients with MRCC are considered entering in a chronic disease Rendering patients available for subsequent lines of treatment, which could be compromised if more patient are progressing in early times The questions is more to use subsequently all the main active drugs with different mode of actions, whatever the sequence (except 1 st line) until there is a clear advantage of a given strategy which is not available, yet. (1) 1. Escudier B et al. Ann Oncol 2014

10 DOES ANY REASON TO SPEED FOR A CHANGE IN THE MODE OF ACTION OF DRUGS : THE ANSWER IS NO PFS nivolumab (1) axitinib (2) Axitinib provides the better rapid control of progressive MRCC compared to nivolumab Axitinib : 6.7 months vs. Nivolumab : 4.6 months Gain also obtained in patient already primarily resistant to sunitinib in first line months 1. Motzer R et al. N Engl J Med 2015 ; 2. Rini B et al. Lancet 2011

11 DOES AXITINIB HAS ANY IMPACT ON OVERALL SURVIVAL : THE ANSWER IS YES Choice of a comparator : Axitinib vs. sorafenib vs. Nivolumab vs. everolimus Cabozantinib vs. everolimus While it was already known that there is an OS gain in favor of an anti-angiogenic vs. an mtor inhibitor (1) 1. Hutson T et al. J Clin Oncol 2014

12 DOES AXITINIB HAS ANY IMPACT ON OVERALL SURVIVAL : THE ANSWER IS YES Difference in eligible population : MSKCC population Nivolumab (1) % Axitinib (2) % Favorable Intermediate Poor Patients in nivolumab group had already a better outcome in OS than patients with axitinib 1. Motzer R et al. N Engl J Med 2015 ; 2. Rini B et al. Lancet 2011

13 DOES AXITINIB HAS ANY IMPACT ON OVERALL SURVIVAL : THE ANSWER IS YES All together : comparator, analogy between mtor inhibitors and included population in Checkmate 025, AXIS and INTORSECT Support considering that at least axitinib should provide a similar OS gain as sorafenib over an mtor inhibitor 1. Motzer R et al. N Engl J Med 2015 ; 2. Hutson T et al. J Clin Oncol 2014 ; 3. Motzer R et al. Lancet Oncol 2013

14 PATIENT INFORMATION IV vs. oral Treatment every 2 weeks vs. clinics every 2 weeks at beginning for axitinib dose titration then every 2 to 3 months If not considering only the money back to the daily hospital care

15 CONDUCT OF POSITIONNING VEGF TKI (axitinib) vs. nivolumab MRCC is a VEGF driven tumor Early PFS decrease more present in nivolumab vs. axitinib Gain in OS : Comparator everolimus vs. sorafenib Population INTORSECT Patient information Axitinib vs. Cabozantinib Gain in OS : idem Dose adaptation in favor of axitinib Therapeutic balance with side effects profile in favor of axitinib

16 DOES AXITINIB HAS ANY IMPACT ON OVERALL SURVIVAL : THE ANSWER IS YES All together : comparator, analogy between mtor inhibitors and included population in METEOR, AXIS and INTORSECT Support considering that at least axitinib should provide a similar OS gain as sorafenib over an mtor inhibitor 1. Choueiri T et al. N Engl J Med 2015 ; 2. Hutson T et al. J Clin Oncol 2014 ; 3. Motzer R et al. Lancet Oncol 2013

17 DOSE OPTIMISATION/ADAPTATION axitinib (1) cabozantinib (2) Starting dose 5 mg BID n=359 (100%) Dose reduction <5 mg BID n=88 (25%) No dose change 5 mg BID n=139 (39%) Mean duration: 161 days Dose escalation >5 mg BID n=132 (37%) 60 mg 40 mg Dose decrease 60% Median dose 44 mg Highest titration to 7 mg BID n=60 (17%) Mean duration (7 mg BID): 92 days Highest titration to 10 mg BID n=71 (20%) Mean duration (10 mg BID): 127 days 20 mg Patients whose dose increased and then reduced n=71 (20%) Axitinib has a more optimal dose adaptation including increase of dosage than cabozantinib 1. Rini B et al. Lancet 2011; 2. Choueiri T et al. N Engl J Med 2015

18 THERAPEUTIC BALANCE WITH SIDE EFFECTS PROFILE IN FAVOR OF AXITINIB Axitinib is «easy» to use after sunitinib and pazopanib Based on previous tolerance of sunitinib and pazopanib Oncologist knows and patient knows Axitinib has the narrow target focus on VEGF so less «off» target AE, over all available drugs If 1 st line VEGFR TKI AE was ok or ~ ok, axitinib in 2 nd line has major chance to be OK, no surprise. So could be comforting for the oncologist and the patient

19 THERAPEUTIC BALANCE WITH SIDE EFFECTS PROFILE IN FAVOR OF AXITINIB Adverse event all grade Axitinib (1) % Cabozantinib (2) % Diarrhea Fatigue Decreased appetite Nausea Vomiting Hand-foot syndrome Weight decreased Stomatitis Transaminases (ASAT/ALAT) -/- 16/18 1. Motzer R et al. Lancet Oncol 2013 ; ; 2. Choueiri T et al. N Engl J Med 2015

20 CONCLUSION Nivolumab vs. Axitinib Just a matter of changing mode of action Data on OS could be challenged by indirect arguments For the majority of patients not scientifically needed Whatever aggressive disease Whatever tumor burden Cabozantinib vs. Axitinib Just a matter of therapeutic balance Data on OS could be challenged by indirect arguments No discussion : axitinib has clearly a more favorable therapeutic balance

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