Adjuvant therapy - Dr. Roda Amaria

Dr. Roda Amaria presents the latest on adjuvant therapy for melanoma at the MRF's Patient Symposium at MD Anderson Cancer Center on January 31, 2015.

1. Adjuvant and Neoadjuvant Therapy in Melanoma
R. Amaria, MD
Assistant Professor, Melanoma Medical Oncology
1/31/2015

2. •Adjuvant therapy: additional
cancer treatment given after
surgery is complete to lower
the risk of the cancer returning
•Neoadjuvant therapy:
treatment given as a first step
to shrink a tumor before
surgery is performed

3. Adjuvant Therapy for Stage III
Disease
Surgery Adjuvant therapy

4. Ideal Adjuvant Therapy
•Effective in destroying microscopic deposits of
melanoma that could potentially be present after
surgery
•Has limited or easily manageable toxicity

5. FDA Approved Medical Adjuvant Therapy
•Interferon-αand Pegylated interferon

6. Clinical Trials for Adjuvant Therapy
•Vaccines
•New immunotherapies-ipilimumab, anti PD-1 antibodies
Patients with Surgically
Removed Stage IIIa-IIIc
melanoma
Ipilimumab
10mg/kg
Placebo
Placebo Ipilimumab
Median time to
relapse
17 months 26 months
Median overall
survival
Not statistically
different
Notstatistically
different
Significanttoxicity
rate
2% 49%

7. Neoadjuvant Therapy for
Stage III Disease and Limited
Stage IV disease
Surgery Adjuvant therapy
Neoadjuvant
Therapy

8. Ideal Neoadjuvant Therapy
•Effective in shrinking down tumor rapidly
•Has easily manageable or predictable toxicity profile
•Facilitates understanding of mechanisms of
response to therapy

9. 87yo man with stage IIIc BRAF Mutated Melanoma
November 2014
January 2015
BRAF/MEK
Inhibition

10. November 2014
January 2015
2 cycles of
biochemotherapy
60 year old man with locally advanced sinonasal melanoma

11. Patients with stage
IIIB/IIIC or
oligometastatic stage
IV (<3 lesions), + BRAF
mutation
Blood draw
and tumor
biopsy
Pre-treatment
Neoadjuvant
BRAF/MEK x 8
weeks
Blood draw
and tumor
biopsy
at surgery
Restaging CT scans
every
3 months with blood
draws
Arm A
Upfront surgery
Arm B
Neoadjuvant
BRAFi/MEKI
Surgical
resection
Restaging via
CTs followed by
surgical
resection
Scheduled
within 0-4
weeks
On treatment
biopsy / blood
draw (arm B
only)
Adjuvant
BRAF/MEK x
44 weeks
Standard of care
adjuvant therapy
(interferon vs.
observation)
Follow up
Neoadjuvant Therapy Clinical Trials
Follow up

12. Patients with
stage IIIB/IIIC or
oligometastatic
stage IV
(≤3 lesions)
Blood draw
and tumor
biopsy
Pre-treatment
Blood draw
and tumor
harvested
at surgery
Restaging
CT scans
every 12
weeks
n=20
n=20
Arm A
Neoadjuvant
Nivolumab
(4 doses)
Surgery
On treatment
biopsy /
blood draw
(prior to
dose 2 and
dose 3)
Adjuvant
Nivolumab x 6
months
Arm B
Neoadjuvant
Ipilimumab
& Nivolumab
(3 doses)
Surgery
Adjuvant
Nivolumab x 6
months
Follow up
Follow up
Neoadjuvant Therapy Clinical Trials

13. Adjuvant and Neoadjuvant Therapy Summary
•Adjuvant therapy is administered after surgery to
lessen the risk of melanoma recurring
–Interferon/Pegylated Interferon are FDA
approved options
–Clinical trials are ongoing
•Neoadjuvant therapy is given to shrink tumor
down before surgery
–Multiple clinical trials are ongoing or planned

14. Thank you for your attention
Questions?