Source:	
  	
  Depiction	
  courtesy	
  of	
  Genentech	
  

By	
  Will	
  Roettger	
  
Principal	
  Consultant	
  

20/20...
Page	
  
Introduction/Background	
  

5-­‐7	
  

PD-­‐1/PD-­‐L1	
  Targeted	
  Agents	
  	
  

8-­‐10	
  

PD-­‐1/PD-­‐L1	...
Will	
  Roettger	
  is	
  an	
  established	
  career	
  professional	
  in	
  the	
  pharmaceutical	
  and	
  
biotech	
 ...
4	
  
5	
  
Source:	
  	
  
1.  Oelke	
  et	
  al.	
  and	
  Schneck	
  Trends	
  in	
  MolecMed	
  (2005)	
  
2.  Keir,	
  Annu	
  Re...
7	
  
8	
  
Tumor	
  Type	
  

Estimated	
  PD-­‐L1	
  
Prevalence	
  

NSCLC	
  (SCC)	
  

50%	
  

NSCLC	
  (adeno)	
  

45%	
  

Co...
Nivolumab	
  
(BMS936558)	
  

Lambrolizumab	
  
(MK-­‐3475)	
  

Pidilizumab	
  	
  
(CT-­‐011)	
  

MPDL3280A	
  

Compa...
11	
  
Trademark:	
  
Generic	
  Name:	
  

nivolumab	
  

Synonyms:	
  

BMS-­‐936558,	
  MDX-­‐1106,	
  ONO-­‐4538	
  

MOA:	
 ...
Trademark:	
  
Generic	
  Name:	
  

Not	
  available	
  

Synonyms:	
  

BMS-­‐936559,	
  MDX-­‐1105	
  

MOA:	
  

Fully...
Trademark:	
  
Generic	
  Name:	
  

lambrolizumab	
  

Synonyms:	
  

MK3475,	
  SCH900475	
  

MOA:	
  

Humanized	
  mA...
Trademark:	
  
Generic	
  Name:	
  

Not	
  available	
  

Synonyms:	
  

MPDL3280A,	
  RG7446	
  

MOA:	
  

A	
  human	
...
Trademark:	
  
Generic	
  Name:	
  

pidilizumab	
  

Synonyms:	
  

CT-­‐011,	
  	
  

MOA:	
  

Humanized	
  mAb	
  anti...
Nivolumab	
  
BMS936558,	
  ONO4538	
  
PD-­‐1	
  checkpoint	
  inhibitor,	
  fully	
  human	
  mAb	
  anti-­‐
PD-­‐1	
  I...
Nivolumab	
  
• 
• 
• 
• 

ORR:	
  31%	
  (n=107)	
  
ORR:	
  41%	
  @	
  3	
  mg/kg	
  Q2W	
  (n=17)	
  
mPFS:	
  3.7	
  ...
19	
  
20	
  
Nivolumab	
  Efficacy	
  in	
  Phase	
  I	
  Trial	
  (NCT00730639)	
  
Tumor	
  	
  

No.	
  Patients	
  

NSCLC	
  (1-­‐10...
Nivolumab	
  NSCLC	
  Efficacy	
  in	
  Phase	
  I	
  Trial	
  (NCT00730639)	
  
Stable	
  Disease	
  Rate	
  

Median	
  OS...
Combined	
  Regimen	
  (Nivoilumab	
  +	
  Yervoy)	
  
Nivolumab	
   Yervoy	
  (mg/
(mg/kg)	
  
kg)	
  
3	
  
0.3	
  
3	
 ...
Nivolumab	
  Clinical	
  Trials	
  
NSCLC	
  

RCC	
  

Melanoma	
  

Phase II Trials

Phase II Trials

Phase II Trials

1...
Tumor	
  

N	
  

Trial	
  ID	
  

Melanoma	
  

915	
  

NCT01844505	
  

Global	
  

recruiting	
  

6/2013	
  

1/2017	...
2013

2014

2015

Complete 11/2014

NSCLC
(2nd Line
advanced
metastatic)

2nd

RCC
Line

(advanced
metastatic)

2016

File...
2013

2014

2015

Complete 11/2014

NSCLC
(2nd Line
advanced
metastatic)

2nd

RCC
Line

(advanced
metastatic)

2016

File...
28	
  
29	
  
30	
  
31	
  
32	
  
33	
  
34	
  
35	
  
Will	
  Roettger	
  

Principal	
  Consultant	
  
20/20	
  Market	
  Insights,	
  LLC	
  
908-­‐391-­‐4362	
  
will.roettg...
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PD1 & PD L1 Targeted Agents - Nivolumab Clinical & Commercial Development (110113)

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This is a briefing on the PD-1 and PD-L1 targeted agents. This briefing provides a summary of the agents in clinical development for the treatment of cancer. The briefing specifically focusses on the clinical and commercial development of nivolumab which includes a product profile, clinical development program and timeline, SWOT, potential issues, strategy, etc. More details on the products contained in this briefing can be obtained upon special request.

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  • Great presentation. Promising approaches. Thanks! For better options in treatment, please, visit cancercuremedicine.com, read: http://www.amazon.com/s/ref=nb_sb_noss_1/183-5035389-4416932?url=search-alias%3Daps&field-keywords=travis+christofferson
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PD1 & PD L1 Targeted Agents - Nivolumab Clinical & Commercial Development (110113)

  1. 1. Source:    Depiction  courtesy  of  Genentech   By  Will  Roettger   Principal  Consultant   20/20  Market  Insights,  LLC   November  3,  2013  
  2. 2. Page   Introduction/Background   5-­‐7   PD-­‐1/PD-­‐L1  Targeted  Agents     8-­‐10   PD-­‐1/PD-­‐L1  Product  Profiles     11-­‐19   Nivolumab  Clinical  Development   20-­‐27   Nivolumab  Commercial  Development   28-­‐32   Conclusions   33-­‐35   (Summary,  PD-­‐L1  Targeted  Tumors,  Comparison  Chart)   (nivolumab,  BMS936559,  lambrolizumab,  MPDL3280A  ,  pidilizumab,  nivolumab   vs.  lambrolizumab,  first  to  market  strategy)   (efficacy,  development  program,  phase  III  clinical  trials,  development  timeline)   (SWOT,  Short  &  Long  Term  Planning,  Issues  to  Consider,  Positioning,     2  
  3. 3. Will  Roettger  is  an  established  career  professional  in  the  pharmaceutical  and   biotech  industry.  Having  worked  for  Novartis,  AstraZeneca,  Merck,  Alexion,  and   Dendreon  he  has  developed  expertise  across  the  therapeutic  areas  of  oncology,   hematology,  and  immunology  for  pipeline  and  launch  products.  He  has  been   instrumental  in  establishing  marketing  intelligence  as  a  core  capability  in   support  of  clinical  and  commercial  new  product  development,  solving  the  many   commercial  challenges  that  high-­‐priced  specialty  products  face  from  a  patient,   provider,  and  investor  perspective.  Additionally  he  has  supported  two  specialty   product  launches,  providing  actionable  insights  and  recommendations  by   integrating  market  research  findings  with  competitive  intelligence.  As  a   principal  for  20/20  Market  Insights,  LLC,  he  is  dedicated  to  providing  clients  with   clear  vision  into  competitor  landscapes,  strategies,  and  product  assessments   that  drive  strategic  business  decisions  in  new  drug  development.   Contact  Information:   Will  Roettger   Principal  Consultant   20/20  Market  Insights,  LLC   908-­‐391-­‐4362   will.roettger@gmail.com   3  
  4. 4. 4  
  5. 5. 5  
  6. 6. Source:     1.  Oelke  et  al.  and  Schneck  Trends  in  MolecMed  (2005)   2.  Keir,  Annu  Rev  Immunol.  2008  26:677-­‐704   3.  Ribas,  N  Engl  J  Med.  366:  2517-­‐2519,  2012   4.  Pardol,  Johns  Hopkins,  Nature  Reviews  Cancer  12,  252-­‐264  (April  2012)   5.  Weber,  J  Semin  Oncol  2010 Positive  signal:  promotes  activation  &  proliferation   Repressive  signal:  promotes  supression   6  
  7. 7. 7  
  8. 8. 8  
  9. 9. Tumor  Type   Estimated  PD-­‐L1   Prevalence   NSCLC  (SCC)   50%   NSCLC  (adeno)   45%   Colon   45%   Melanoma   40%   RCC   20%   As  one  of  the  highest  prevalent  cancers,  NSCLC  represents  a  significant   opportunity  to  leverage  the  effects  of  PD-­‐1/PD-­‐L1  blocking  agents   9  
  10. 10. Nivolumab   (BMS936558)   Lambrolizumab   (MK-­‐3475)   Pidilizumab     (CT-­‐011)   MPDL3280A   Company   BMS   Merck   Genentech/Roche   CureTech   Target/MOA   PD-­‐1   PD-­‐1   PD-­‐L1   PD-­‐1   Human,  IgG4   Humanized,  IgG4   Human,  IgG1       Humanized,  IgG1   Melanoma,  NSCLC,  RCC   Melanoma   Melanoma,  NSCLC,  RCC,   Colon,  Gastric,  HNSCC,   Lymphoma   Melanoma,  pancreatic,   lymphoma,  CRC,  RCC,   MM   Phase  III/(melanoma,  NSCLC,  RCC)   [6-­‐phase  III  trials]   Phase  III/(melanoma)   Phase  II  (NSCLC)   Phase  II  (NSCLC)   Phase  II  (CRC,  lymphoma,   Hep-­‐C  pancreatic,  PCa   Melanoma:  all  cohorts  (ORR=31%)    3mg/kg  Q2W  cohort  (ORR  41%)   NSCLC:  (17%),  RCC  (29%)   Melanoma:  all  cohorts  (ORR>38%)   10mg/kg  Q2W  cohort  (ORR=52%)   NSCLC:  nscc  cohort  ORR=23%),   scc  cohort  (ORR=33%)   Melanoma:  (ORR  29%,  SD   87%  ,  PFS  43%),  NSCLC  (24%)   NSCLC:  all  cohorts  (ORR=23%)   RCC:  (ORR=13%)   +50%  increase  in  CD4,   +40%  increase  in  CD8   Melanoma:  3mg/kg  Q2W  cohort   mOS=20.3  mths   NSCLC:  mOS=9.9  mths   Melanoma:  mPFS=>7  mths   NSCLC:  nscc  cohort  mPFS=9.1   wks),  scc  cohort  (mPFS=23.5  wks)   All  Tumors:  39%  vs.  13%   NSCLC:  100%  vs.  15%   1.  Squamous  NSCLC   2.  RCC   1.  Melanoma   1.  NSCLC   ADCC/CDC  Toxicity   none   none   none   Pneumonitis   3-­‐4%   3-­‐4%   none   All  Grade  3/4    =  14%   •  Fatigue  2%   •  Diarrhea  1%   •  Pruritus  0.3%   •  Nausea  0.3%   •  Hb  decrease  0.3%   All  Grades  3/4  =  12.6%   •  Fatigue  1.5%   •  Rash  2.2%   •  Pruritus  0.7%   All  Grade  3/4    =  43%   •  Hyperglycemia  5%   •  Fatigue  4%   •  Increased  ALT  3%   •  Dyspnea  3%   •  Hypoxia  3%   Antibody   Targeted  Tumors   Latest  Clinical  Phase   Development   Activity/response  rates   Efficacy   Fast  Approval  Strategy   (w/phase  II)   Grade  3/4  Adverse  Events   (blocks  PD-­‐L1/PD-­‐L2  )   (blocks  PD-­‐L1/PD-­‐L2  )   (blocks  PD-­‐L1  )   (effector  T-­‐cell  function)   (effector  T-­‐cell  function)   -­‐   none  
  11. 11. 11  
  12. 12. Trademark:   Generic  Name:   nivolumab   Synonyms:   BMS-­‐936558,  MDX-­‐1106,  ONO-­‐4538   MOA:   PD-­‐1  checkpoint  inhibitor,  fully  human  mAb  anti-­‐PD-­‐1  IgG4  receptor  blocker.  Blocks  binding  of  PD-­‐1  to   PD-­‐L1  and  PD-­‐L2   Originating  Company   Ono  Pharmaceuticals,  Ltd./Medarex   Licensing  Company   Bristol-­‐Myers  Squibb   Formulation/Dose   IV  infusion,  3  mg/kg  solution  intravenously  Q2W,  [12  cycles  (48  doses),  4-­‐doses  per  cycle]   1st  Launch/Indication   /Metastatic  NSCLC   2nd  Launch/Indication   /Metastatic  RCC  or  Metastatic  melanoma   Patent  No./Expiration   COM  2027  (US)   Sales  Force  Size   Cost   Not  available   Comments   Pneumonitis  AEs  of  3-­‐4%,  3-­‐deaths  to  date,  1-­‐CRC,  2-­‐nsclc.  No  known  Fc  function  (ADCC,  CDC).  6-­‐phase   III  trials  are  underway  in  NSCLC,  Melanoma,  and  RCC.   12  
  13. 13. Trademark:   Generic  Name:   Not  available   Synonyms:   BMS-­‐936559,  MDX-­‐1105   MOA:   Fully  human  mAb,  PD-­‐L1  IgG4  ligand  blocker.  Blocks  binding  of  PD-­‐L1  to  PD-­‐1  and  B7-­‐1.  Does  not  block   binding  of  PD-­‐L2  to  PD-­‐1   Originating  Company   Ono  Pharmaceuticals,  Ltd./   Licensing  Company   Bristol-­‐Myers  Squibb   Formulation/Dose   IV  infusion/0.1  –  10mg/kg  Q2W  [phase  I,  16  cycles  (48  doses),  3-­‐doses  per  cycle]   1st  Launch/Indication   /Metastatic  Melanoma   2nd  Launch/Indication   /Metastatic  NSCLC   Patent  No./Expiration   Sales  Force  Size   Cost   Not  available   Comments   Development  was  dropped  in  option  to  move  ahead  with  nivolumab  –  a  PD-­‐1  receptor  blocker.  No   reported  pneumonitis  in  BMS-­‐936559.   13  
  14. 14. Trademark:   Generic  Name:   lambrolizumab   Synonyms:   MK3475,  SCH900475   MOA:   Humanized  mAb  anti-­‐PD-­‐1,  IgG4,  receptor  blocker.  Blocks  binding  of  PD-­‐1  to  PD-­‐L1  and  PD-­‐L2   Originating  Company   Licensing  Company   Merck/Schering   Formulation/Dose   IV  infusion  over  30  minutes,  10  mg/.kg  Q2W  or  10mg/kg  Q3W  or  2mg/kg  Q2W,  [Phase  I,  11-­‐cycles  (34   doses),  3-­‐doses  per  cycle]   1st  Launch/Indication   /Metastatic  Melanoma   2nd  Launch/Indication   /Metastatic  NSCLC   Patent  No./Expiration   US  20130071403  A1   Sales  Force  Size   Cost   Not  available   Comments   Pneumonitis  AEs  of  3-­‐4%,     14  
  15. 15. Trademark:   Generic  Name:   Not  available   Synonyms:   MPDL3280A,  RG7446   MOA:   A  human  Fc  optimized  anti-­‐PD-­‐L1  mAb,  IgG1,  ligand  blocker    -­‐    binds  to  PD-­‐L1,  blocking  its  binding  to  and   activation  of  its  receptor,  PD-­‐1.  Fc  optimization  does  not  induce  either  antibody-­‐dependent  cytotoxicity   (ADCC)  or  complement-­‐dependent  cytotoxicity  (CDC).   Originating  Company   Licensing  Company   Genentech/Roche   Formulation/Dose   IV  Infusion  of  1200  mg  on  Day  1  of  21-­‐day  cycles  for  a  maximum  of  16  cycles,  Q3W,     1st  Launch/Indication   /Metastatic  NSCLC   2nd  Launch/Indication   /Metastatic  Melanoma   Patent  No./Expiration   Sales  Force  Size   Cost   Not  available   Comments   20%  clinical  benefit  in  PD-­‐L1  negative  tumors  has  been  shown.  The  Fc  portion  of  anti-­‐body  is  engineered   to  prevent  depletion  of  effector  T-­‐cells  by  ADCC  thereby  allowing  PD-­‐1  and  PD-­‐L2  interaction  to  remain   intact  in  pleural  tissues.  As  a  result  no  pneumonitis  has  been  seen.   15  
  16. 16. Trademark:   Generic  Name:   pidilizumab   Synonyms:   CT-­‐011,     MOA:   Humanized  mAb  anti-­‐PD-­‐1,  IgG1,  receptor  blocker.  Blocks  binding  of  PD-­‐1  to  PD-­‐L1  and  PD-­‐L2  resulting   in  the  attenuation  of  apoptotic  processes  in  lymphocytes,  primarily  effector/memory  T  cells,  and  the   augmentation  of  the  anti-­‐tumor  activities  of  NK  cells.   Originating  Company   CureTech   Licensing  Company   Formulation/Dose   IV  infusion,  0.2  to  0.6  mg/kg  (dose  to  be  determined)   1st  Launch/Indication   Diffuse  Large  B  Cell  Lymphoma  (DLBCL)   2nd  Launch/Indication   mCRC   Patent  No./Expiration   US  7332582B2,  EP  1575484A   Sales  Force  Size   None   Cost   Not  available   Comments   As  of  January  2013,  Teva  dropped  their  development  agreement  with  Curetech  on  this  product.  At  this   point  Teva  is  without  a  development  partner  and  continues  ahead  with  phase  II  trials.   16  
  17. 17. Nivolumab   BMS936558,  ONO4538   PD-­‐1  checkpoint  inhibitor,  fully  human  mAb  anti-­‐ PD-­‐1  IgG4  receptor  blocker.  Blocks  binding  of  PD-­‐1   to  PD-­‐L1  and  PD-­‐L2   Ono  Pharmaceuticals,  Ltd./Medarex   BMS   IV  infusion,  3  mg/kg  solution,  Q2W,  [phase  I,  12   cycles  (48  doses),  4-­‐doses  per  cycle]   Not  yet  approved/NSCLC   Not  yet  approved/Melanoma   COM  2027  (US)   Lambrolizumab   Synonyms   MOA   Originating  Company   Licensing  Company   Formulation/Dose   MK3475,  SCH900475   Humanized  mAb  anti-­‐PD-­‐1,  IgG4,  receptor  blocker.   Blocks  binding  of  PD-­‐1  to  PD-­‐L1  and  PD-­‐L2   Schering   Merck   IV  infusion  over  30  minutes,  10  mg/.kg  Q2W  or  10mg/ kg  Q3W  or  2mg/kg  Q2W,  [Phase  I,  11-­‐cycles  (34   doses),  3-­‐doses  per  cycle]   1st  Approval/Indication   Not  yet  approved/NSCLC   2nd  Approval/Indication   Not  yet  approved/Melanoma   Patent  No./Expiration   Sales  Force  Size   phase  I,  12  cycles  (48  doses)   Duration  of  Therapy   Phase  I,  11-­‐cycles  (34  doses)   Not  available   Pricing   Not  available   Not  available   Cost  of  Treatment   Not  available   17  
  18. 18. Nivolumab   •  •  •  •  ORR:  31%  (n=107)   ORR:  41%  @  3  mg/kg  Q2W  (n=17)   mPFS:  3.7  months   Yervoy  treated  ORR:  20%   Lambrolizumab   Efficacy:  Melanoma   •  ORR:  17%  RECIST  [17.6%  NSCC,  16.7%  SCC]  1-­‐yr   survival=42%,  2-­‐yr  survival=24%,  mOS=9.9  mths   (n=129)   All  Grade  3/4    =  14%   •  Fatigue  2%   •  Diarrhea  1%   •  Pruritus  0.3%   •  Nausea  0.3%   •  Hb  decrease  0.3%   Efficacy:  NSCLC   ADEs   Pneumonitis:  4%  (any  grade),  1%  (grade  3/4)   Notable  Toxicities   •  •  •  •  •  ORR:  38%  (n=117)   ORR:  52%  @  10  mg/kg  Q2W  (n=52),  CR=10%   mPFS:  >7  months   Yervoy  treated  ORR:  62%  @  10  mg/kg  Q2W  (n=13)   Yervoy  naïve  ORR:  49%  @  10  mg/kg  Q2W  (n=39)   •  ORR:  21%  RECIST(n=38)   All  Grades  3/4  =  12.6%   •  Fatigue  1.5%   •  Rash  2.2%   •  Pruritus  0.7%   Pneumonitis:  4.4%  (grade  1/2)   Warnings   Not  available   NCCN  Guideline   Not  available   Manufacturer   Not  available   Sales   18   Not  available  
  19. 19. 19  
  20. 20. 20  
  21. 21. Nivolumab  Efficacy  in  Phase  I  Trial  (NCT00730639)   Tumor     No.  Patients   NSCLC  (1-­‐10)   127   MEL  (0.1-­‐10)   RCC  (1  or  10)   (dose,  mg/kg)   Duration  of  Response   Median  PFS   Median  OS   (mths)   (1-­‐yr)   (2-­‐yr)   16%   17.0   2.3   9.6   43%   32%   107   31%   24.0   3.7   16.8   61%   44%   34   29%   12.9   7.3   >22   70%   52%   (n)   ORR   (mths)   21   (mths)   OS     OS    
  22. 22. Nivolumab  NSCLC  Efficacy  in  Phase  I  Trial  (NCT00730639)   Stable  Disease  Rate   Median  OS   All  doses   16.7%   14.8%   9.2     0%   26.7%   8.0   22.2%   5.6%   9.5   10   NSCC   ORR   3   SCC   Dose     1   Histology   23.8%   14.3%   10.5   All  doses   17.6%   6.8%   10.1     1   5.6%   5.6   9.9   3   26.3%   10.5%   18.2   10   18.9   5.4%   7.4   (mg/kg)   %   (≥24  weeks  )   22   (months)  
  23. 23. Combined  Regimen  (Nivoilumab  +  Yervoy)   Nivolumab   Yervoy  (mg/ (mg/kg)   kg)   3   0.3   3   1   1   3   3   3   All  doses   Evaluable   patients   14   17   15   6   52   CR  (n)   PR  (n)   ORR   1   3   1   0   5   2   6   5   3   16   21%   53%   40%   60%   40%   23   ≥80%  Tumor   reduction  at  8  wks     4  (28%)   7  (41%)   5  (33%)   0   16  (31%)  
  24. 24. Nivolumab  Clinical  Trials   NSCLC   RCC   Melanoma   Phase II Trials Phase II Trials Phase II Trials 1.  Nivolumab in advanced or metastatic squamous cell NSCLC, NCT01721759, n=100, i=11/2012, f=2/2014 1.  Nivolumab in clear cell advanced RCC, NCT01354431, n=150, i=5/2011, f=5/2013 1.  Nivlumab w/ipilimumab in advanced or metastatic melanoma, NCT01783938, n=80, i=4/2013, f=8/2014 Phase III Trials Phase III Trials Phase III Trials 1.  Nivolumab vs. docetaxel 2L advanced or metastatic squamous cell NSCLC, NCT01642004, n=264, i=10/2012, f=8/2015 1.  Nivolumab vs. everolimus 2L advanced or metastatic clear cell RCC, NCT01668784, n=822, i=10/2012, f=2/2016 1.  Nivolumab + ipilimumab – 1L Advanced Melanoma, NCT01844505, n=915, i=6/2013, f=1/2017 2.  Nivolumab vs. dacarbazine or carbo/paclitaxel in advanced melanoma following anti CTLA-4, NCT01721746, n=390, i=12/2012, f=5/2015 2.  Nivolumab vs. docetaxel 2L advanced or metastatic nonsquamous NSCLC, NCT01673867,n=574, i=11/2012, f=11/2014 24   3.  Nivolumab vs. dacarbazine, 1L metastatic melanoma, NCT01721772, n=410, i=1/2013, f=6/2020
  25. 25. Tumor   N   Trial  ID   Melanoma   915   NCT01844505   Global   recruiting   6/2013   1/2017   1st  line,  untreated   advanced   unresectable  or   metastatic   Nivolumab  vs.     10:  OS/PFS,   ORR   Melanoma   390   NCT01721746   Global   recruiting   12/2012   5/2015   Post  CTLA-­‐4,   unresectable  or   metastatic   Nivolumab  vs.   dacarbazine  or   carbo  tax   10:  OS,ORR   20:  PFS,   HRQoL   Melanoma   410   NCT01721772   Ex-­‐US   recruiting   1/2013   6/2020   1st  line,  unresectable   or  metastatic   Nivolumab  vs.   dacarbazine   10:  OS   20:  PFS,  ORR   NSCLC   (NSCC)   264   NCT01642004   Global   recruiting   10/2012   8/2015   2nd  line,  post   platinum  failure,   advanced  metastatic   Nivolumab  vs.   docetaxel   10:  OS,ORR   20:PFS     NSCLC   574   NCT01673867   Global   recruiting   11/2012   11/2014   2nd  line,  post   platinum    failure,   advanced  metastatic   Nivolumab  vs.   docetaxel   10:  OS   20:ORR,  PFS   RCC   822   NCT01668784   Global   recruiting   10/2012   2/2016   4th  line,  pre-­‐treated   advanced  or   metastatic  clear  cell   RCC   Nivolumab  vs.   affinitor   (everlimus)   10:OS   (SCC)   Scope   Status   T0   Tf   25   Segment   Treatment   Endpoint  
  26. 26. 2013 2014 2015 Complete 11/2014 NSCLC (2nd Line advanced metastatic) 2nd RCC Line (advanced metastatic) 2016 File 4/2015 Non-Squamous Cell NCT0167387 Estimated approval 10/2015 (PDUFA V, 6-mth priority review) Complete 8/2015 File 1/2016 Estimated approval 7/2016 (PDUFA V, 6-mth priority review) Squamous Cell NCT0167387 Complete 2/2016 File 7/2016 Estimated approval 1/2017 (PDUFA V, 6-mth priority review) clear cell NCT01668784 Complete 11/2014 Melanoma (1st Line advanced metastatic) 2017 File 5/2015 Vs. dacarbazine,or c/p NCT01721746 Complete 8/2015 + ipilimumab NCT01844505 Estimated approval 12/2015 (PDUFA V, 6-mth priority review) File 1/2016 Estimated approval 7/2016 (PDUFA V, 6-mth priority review) Estimated approval 3/2021 (PDUFA V, 6-mth priority review) Vs. dacarbazine NCT01721772 26  
  27. 27. 2013 2014 2015 Complete 11/2014 NSCLC (2nd Line advanced metastatic) 2nd RCC Line (advanced metastatic) 2016 File 4/2015 Non-Squamous Cell NCT0167387 Phase II Study Complete 2/2014 Fast  Track   Estimated approval 10/2015 (PDUFA V, 6-mth priority review) Complete 8/2015 File 1/2016 Estimated approval 7/2016 (PDUFA V, 6-mth priority review) Squamous Cell NCT0167387 Phase II Study Complete 5/2013 Fast  Track   Complete 2/2016 File 7/2016 Estimated approval 1/2017 (PDUFA V, 6-mth priority review) clear cell NCT01668784 Complete 11/2014 Melanoma (1st Line advanced metastatic) 2017 File 5/2015 Vs. dacarbazine,or c/p NCT01721746 Phase II Study Complete 8/2014 Fast  Track   + ipilimumab NCT01844505 Vs. dacarbazine NCT01721772 Complete 8/2015 Estimated approval 12/2015 (PDUFA V, 6-mth priority review) File 1/2016 Estimated approval 7/2016 (PDUFA V, 6-mth priority review) Estimated approval 3/2021 (PDUFA V, 6-mth priority review) 27  
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  36. 36. Will  Roettger   Principal  Consultant   20/20  Market  Insights,  LLC   908-­‐391-­‐4362   will.roettger@gmail.com   36  

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