In conjunction with a Key Opinion Leader, Dr. Peter Lee MD Chair, Department of Immuno-Oncology at City of Hope Comprehensive Cancer Center, CA, several Informa analysts discuss the major developments of the conference and key take-aways via a Webinar. Watch our recording of Biomedtracker's Robert Jeng, Ph,D., Citeline's Allison Bruce, Scrip's Mary Jo Laffler, and Datamonitor Healthcare's Zachary McLellan as they download and debrief following the always-exciting ASCO weekend. View and listen to the full webinar here https://www.youtube.com/watch?v=7yMsCb3R5X8

1. Analyzing ASCO 2016:
Developments, takeaways,
and implications from the
conference

2. Analyzing ASCO 2016:
Developments, takeaways, and
implications from the conference
Moderator
Mary Jo Laffler
US Head of Commercial Content, Pink Sheet & Scrip
Panelists
Dr. Peter P. Lee, MD, Chair, Department of Immuno-Oncology at City of Hope
Comprehensive Cancer Center, CA
Robert Jeng, PhD, Senior Scientific Analyst for Biomedtracker
Allison Bruce, Principal Analyst in Oncology for Citeline
Zachary McLellan, Analyst in Oncology for Datamonitor Healthcare

3. Pharma intelligence | informa3
A phase III trial of nivolumab (NIVO) combined with ipilimumab (IPI) in treatment-
naive patients with advanced melanoma (MEL)
• NIVO 1 mg/kg Q3W + IPI 3 mg/kg Q3W for 4
doses (followed by NIVO 3 mg/kg Q2W), NIVO 3
mg/kg Q2W + placebo, or IPI 3 mg/kg Q3W for 4
doses + placebo, until progression or
unacceptable toxicity
• Pts stratified by PD-L1 status, BRAF mutation
status, and M-stage
• Treatment-naïve pts (N=945) were randomized
• At ≥18 months follow-up, median PFS continued
to be significantly longer for NIVO+IPI and NIVO
vs IPI (P<0.001), and was numerically longer for
NIVO+IPI vs NIVO alone
• Median duration of response in 181/314 (57.6%)
NIVO+IPI responders has not been reached, and
was 22.3 and 14.4 months in 138/316 (43.7%)
NIVO and 60/315 (19.0%) IPI responders
Conclusions:
NIVO+IPI and NIVO alone continue to
demonstrate superior clinical activity vs IPI
monotherapy. NIVO+IPI appears to have
greater efficacy than either agent alone,
regardless of PD-L1 expression or BRAF
mutation status.
CheckMate 067: PD-1 & CTLA4 HR, hazard ratio; NR, not reach

4. Pharma intelligence | informa4
A phase I/II study of pembrolizumab (pembro) in combination with dabrafenib (D)
and trametinib (T) for BRAF-mutant advanced melanoma
• 1:1 to pembro 2 mg/kg IV Q3W with D 150
mg orally BID + T 2 mg orally daily or placebo
+ D + T
• unresectable or metastatic stage III/IV
BRAFV600E/K- mutant melanoma and no prior
therapy are to be randomized
• Primary end point is PFS; secondary end
points are ORR, response duration, and OS
• Recruitment in KEYNOTE-022 is ongoing
Conclusions:
Phase I: The approved doses of pembro in
combination with D + T administered
concurrently provided a manageable toxicity
profile in pts with BRAF-mutant melanoma. A
phase II study will further evaluate safety and
efficacy of this triplet combination as first-line
therapy for BRAF-mutant melanoma.
Phase II: ongoing
KEYNOTE-022:

5. Pharma intelligence | informa5
Immunotherapy Triplet Combinations by Phase and Status
Source: Trialtrove® as of June 2016
0
0.5
1
1.5
2
2.5
3
3.5
4
4.5
5
I
I/II
II
Terminated
Planned
Open
Completed

6. Moderator
Mary Jo Laffler
US Head of Commercial Content, Pink Sheet & Scrip
Panelists
Dr. Peter P. Lee, MD, Chair, Department of Immuno-Oncology at
City of Hope Comprehensive Cancer Center, CA
Robert Jeng, PhD, Senior Scientific Analyst for Biomedtracker
Allison Bruce, Principal Analyst in Oncology for Citeline
Zachary McLellan, Analyst in Oncology for Datamonitor Healthcare
Analyzing ASCO 2016: Questions for the panel
Questions can be submitted in the chat box at any time

7. Pharma intelligence | informa7
A phase III trial of palbociclib with letrozole compared with letrozole alone in
postmenopausal women with ER+/HER2– advanced breast cancer
• P (oral 125 mg/d; 3 wks on/1 wk off) + L (2.5
mg/d continuously) or PLB + L every 28 days
until disease progression.
• 666 postmenopausal pts with no prior
systemic therapy for advanced breast cancer
were randomized 2:1.
• Median PFS was 24.8 mo (P+L) vs 14.5 mo
(PLB+L) (HR=0.58 [0.46–0.72], P<0.000001).
ORR was improved with P+L (42% vs 35%,
P=0.031; 55.3% vs 44.4% in pts with
measurable disease [P=0.013]). CBR was
85% vs 70% (P<.0001).
• Serious AEs occurred in 19.6% of patients in
the P + L arm versus 12.4% with PBL + L.
36% of patients required dose reduction.
Conclusions:
Significant clinical benefit in ER+/HER2–
advanced breast cancer pts who had not
received prior systemic therapy for their
advanced disease.
Confirms PFS benefit from PALOMA-1.
Longest front-line improvement in median PFS
to date for advanced ER+ breast cancer pts.
Phase III studies ongoing.
PALOMA-2: CDK4/6

8. Pharma intelligence | informa8
A phase II study of abemaciclib, as monotherapy, in patients with HR+/HER2-
breast cancer, after chemotherapy for advanced disease
• Abemaciclib (200 mg) administered orally on
a continuous schedule every 12 hours until
unacceptable toxicity or progressive disease.
• 132 pts treated, >90% visceral metastases.
• Median of 3 lines of prior therapy for
metastatic disease, including a median of 2
lines of chemotherapy for advanced disease.
• Confirmed ORR (per RECIST v1.1) was
19.7%, the clinical benefit rate (CR + PR +
SD ≥ 6 mos) was 42.4%, median PFS was
6.0 mos, and median OS was 17.7 mos. The
disease control rate (CR + PR + SD) was
67.4%.
• Most common G3 AE was diarrhea at 20%.
• 49% of patients required at least 1 dose
reduction.
Conclusions:
Abemaciclib demonstrates single agent activity
in heavily pretreated, refractory HR+/HER2-
metastatic breast cancer. Treatment was
mostly well tolerated, allowing continuous
exposure to therapy.
Phase III MONARCH 2 and MONARCH 3 trials
are ongoing.
MONARCH1: CDK4/6

9. Moderator
Mary Jo Laffler
US Head of Commercial Content, Pink Sheet & Scrip
Panelists
Dr. Peter P. Lee, MD, Chair, Department of Immuno-Oncology at
City of Hope Comprehensive Cancer Center, CA
Robert Jeng, PhD, Senior Scientific Analyst for Biomedtracker
Allison Bruce, Principal Analyst in Oncology for Citeline
Zachary McLellan, Analyst in Oncology for Datamonitor Healthcare
Analyzing ASCO 2016: Questions for the panel
Questions can be submitted in the chat box at any time

10. Pharma intelligence | informa10
A phase II pivotal randomized study of brigatinib (BRG) in patients (pts) with
crizotinib (CRZ)-refractory ALK+ non-small cell lung cancer (NSCLC)
• oral BRG at 90 mg qd (arm A) or 90 mg qd for
7 d followed by 180 mg qd (arm B)
• pts were randomized (arm A/B, n=112/n=110)
• Median of 3 lines of prior therapy for
advanced disease, including a median of 2
lines of chemotherapy for advanced disease.
• As of 7 Dec 2015, 63%/74% (A/B) were
ongoing; median time on treatment was 25
wk/23 wk. Investigator-assessed ORR in A:
46% (95% CI 36–55%; 39 confirmed
responses + 12 single responses awaiting
confirmation), including 1 confirmed complete
response (CR); ORR in B: 54% (95% CI 44–
63%; 49 confirmed responses + 10 single
responses awaiting confirmation), including 5
confirmed CRs. Median PFS in A/B: 8.8
mo/11.1 mo (events per arm [A/B]: 44/25).
Conclusions:
In each arm, BRG yielded substantial
responses and robust PFS, with an acceptable
safety profile. A ph 3 study of BRG at 90 mg qd
for 7 d followed by 180 mg qd vs CRZ in TKI-
naive, advanced ALK+ NSCLC is planned.
ALTA: ALK inhibitor

11. Pharma intelligence | informa11
Randomized open-label phase III trial of alectinib (ALC) versus crizotinib (CRZ) in
ALK-inhibitor naive ALK-positive NSCLC
• ALK+ NSCLC pts were randomized 1:1 either
to receive ALC (300 mg b.i.d.) or CRZ (250
mg b.i.d.)
• 207 pts were enrolled
• The PFS HR of ALC arm to CRZ arm was
0.34 (99.6826% CI: 0.17-0.70, stratified log-
rank p<0.0001). Median PFS was not
reached (95% CI: 20.3-Not Estimated) in ALC
arm while it was 10.2 months (95%CI: 8.2-
12.0) in CRZ arm.
• Superiority in PFS had been demonstrated
Conclusions:
At J-ALEX IA, ALC demonstrated significantly
prolonged PFS compared with CRZ and was
well tolerated with a favorable AE profile.
J-ALEX: ALK inhibitor

12. Analyzing ASCO 2016:
Developments, takeaways, and
implications from the conference
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