- The abstract presents updated results from a Phase I trial of avelumab for metastatic urothelial carcinoma. The overall response rate was improved slightly compared to previous results, but median overall survival of 7.4 months was slightly lower than other immunotherapies. - While the data show some anti-tumor activity, it is unlikely to differentiate avelumab from other immunotherapies in the crowded second-line bladder cancer setting. Merck is expected to pursue approval in the maintenance setting rather than running a Phase III trial in second-line.

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Cover page, paste image over entire page
Pre-ASCO Report
AMERICAN SOCIETY OF CLINICAL ONCOLOGY ANNUAL MEETING
CHICAGO, ILLINOIS • JUNE 2-6, 2017
2017
NOT A PRODUCT SPONSORED BY ASCO

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Summary
Abstracts from the 53rd Annual meeting of the American Society of Clinical Oncology (ASCO) were
released May 17th at 5pm EDT. The 2017 ASCO meeting will be held in Chicago, Illinois from June 2-6,
2017.
We have highlighted some key abstracts with analyses, along with companies to watch during the
meeting. Included at the end of the report are two helpful lists: one for the ASCO data events we added
tonight and one for the upcoming ASCO catalysts. While this is just a brief overview, we will be available
to discuss any data of interest in further detail. Please email Biomedtracker or call your sales
representative. Additionally, keep an eye out for our ASCO weekend updates and live-coverage when the
meeting takes place.
Upcoming ASCO Conference Coverage Plan
Our team offers various ways to keep you up-to-date on the biggest oncology event of the year. Keep an
eye out for our upcoming coverage over the next few weeks:
May 24* – Pre-Meeting Podcast
As an accompaniment to the Pre-ASCO report, join a panel of Informa Pharma Intelligence analysts as
they hold a roundtable discussion of the abstracts to help you navigate the flood of data in the
abstract release.
June 5 – ASCO Weekend Update
Along with many events added to the Biomedtracker database over the weekend, our analysts will be
attending the ASCO conference and providing their boots-on-the-ground commentary both in our
Biomedtracker events, and in a 'Weekend Update', published before you start your day Monday
morning.
June 8* – Post-Meeting Podcast
A panel of Informa analysts will discuss the major developments of the conference and key take-aways
via a podcast recorded directly after the meeting concludes. Join Biomedtracker's Robert Jeng,
Citeline's Maria Berezina, and Datamonitor Healthcare's Dominique Fontanilla as they debrief
following the conclusion of the conference with their rapid takeaways and key highlights.
Late June/Early July – Post-ASCO Report
Once our analysts return from the conference and all of the Informa Pharma coverage is completed,
the team will publish a comprehensive wrap-up of the conference and provide insights on material
updates in various oncology indications.
*Date is tentative and subject to change

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About the Author
Biomedtracker is an independent research service that offers proprietary clinical assessments of
developmental drugs within a comprehensive and intuitive drug information database. Clients from the
pharmaceutical, biotech, and investment industries rely on Biomedtracker for its insight on the likelihood
of approval, commercial potential, and future data and regulatory catalysts for drugs within the
competitive landscape of every important disease and indication. Over recent years, Biomedtracker has
become the leader in providing objective information alongside evidence-based clinical assessments and
investment research on pipeline drugs worldwide.
Disclaimer
All abstracts reprinted with permission © 2017 American Society of Clinical Oncology. All rights reserved.
This is not a product sponsored by ASCO.

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Nivolumab+ Target #of Trials
ipilimumab CTLA-4 83
BMS-986016 LAG-3 9
bevacizumab VEGF 5
daratumumab CD38 5
b-vedotin CD30/TNFRSF8 4
epacadostat IDO 4
erlotinib EGFR 4
urelumab CD137 4
cetuximab EGFR 3
lirilumab KIR 3
Nivolumab
Top 10 Combinations with Targeted/IO Therapies in Development
ByMariaA. BerezinaSource: Trialtrove® |Pharmaintelligence, May2017
Pembrolizumab + Target # of Trials
epacadostat IDO 10
acalabrutinib BTK 6
bevacizumab VEGF 4
axitinib VEGFR, PFGFR 3
Imprime PGG Complement Proteins 3
BGB324 AXL 3
dabrafenib RAF 3
lenvatinib VEGFR, PFGFR, FGFR, cKIT 3
ipilimumab CTLA-4 2
BKT-140 CXCR4 2
Pembrolizumab
Top 10 Combinations with Targeted/IO Therapies in Development
By MariaA. BerezinaSource: Trialtrove® | Pharmaintelligence, May 2017

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Contents
Companies to Watch.....................................................................................................................................7
Notable Late Breaking Abstracts (LBAs) ........................................................................................................8
Biomedtracker Key Drug Analyses.................................................................................................................9
Idhifa for Acute Myelogenous Leukemia (AML) (CELG).............................................................................9
Bavencio for Bladder Cancer (MKGAY)....................................................................................................10
Abemaciclib for Breast Cancer (LLY)........................................................................................................12
Ipatasertib for Breast Cancer (RHHBF) ....................................................................................................13
Veliparib for Breast Cancer (ABBV)..........................................................................................................15
CTL119 for Chronic Lymphocytic Leukemia (CLL)/Small Cell Lymphocytic Lymphoma (SLL) - NHL (NVS)17
Bosulif for Chronic Myelogenous Leukemia (CML) (PFE).........................................................................18
Keytruda for Gastric Cancer (MRK)..........................................................................................................19
Keytruda for Gastric Cancer (MRK)..........................................................................................................21
Opdivo for Hepatocellular (Liver) Cancer (HCC) (Including Secondary Metastases) (BMY).....................23
Tivantinib for Hepatocellular (Liver) Cancer (HCC) (Including Secondary Metastases) (ARQL) ...............24
Lenvima for Hepatocellular (Liver) Cancer (HCC) (Including Secondary Metastases) (ESALY).................26
Entinostat for Melanoma (SNDX) ............................................................................................................28
MOR202 for Multiple Myeloma (MM) (MorphoSys)...............................................................................30
Alecensa for Non-Small Cell Lung Cancer (NSCLC) (RHHBF)....................................................................31
Epacadostat for Solid Tumors (INCY).......................................................................................................33
RG6078 for Solid Tumors (RHHBF) ..........................................................................................................34
BMS-986156 for Solid Tumors (BMY)......................................................................................................36
List of Biomedtracker ASCO Events ..........................................................................................................38
List of Biomedtracker ASCO Catalysts.......................................................................................................39

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Companies to Watch
Incyte Corporation (INCY)
• Leads hot IDO inhibitor race with epacadostat
• Multiple presentations from ECHO-202 study with two oral presentations: #4503 (June 5, 2017)
and #6010 (June 6, 2017)
• Large Phase III program across multiple tumor types already announced
• Epacadostat demonstrating efficacy on top of PD-1s
• Bottom line – positive for INCY
NewLink Genetics (NLNK)
• Oral presentation #105 (June 4, 2017)
• Weak early data for IDO inhibitor but still early
• Opportunity to surprise if established dose in expansion cohort does well
• Lags far behind epacadostat (INCY)
• Bottom line – negative for NLNK
Puma Biotechnology (PBYI)
• Limited data at ASCO but impacted by Perjeta APHINITY details in oral presentation LBA500 (June
5, 2017)
• APHINITY already reported successful outcome
• PBYI’s neratinib vying for migration into adjuvant breast cancer space with Perjeta
• FDA adcomm to be held before ASCO
• Bottom line- negative for PBYI
Syndax Pharmaceuticals (SNDX)
• Poster presentation #9529 (June 3, 2017)
• First data for entinostat in melanoma
• Early but intriguing data in PD-1 failures
• Very small two-drug pipeline with neither approved
• Bottom line – positive for SNDX

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Notable Late Breaking Abstracts (LBAs)
LBA3: Zytiga for Prostate Cancer (JNJ)
Zytiga has been steadily migrating forward in the prostate cancer treatment paradigm, first gaining
approval after chemotherapy and then before chemotherapy. Now, Zytiga is poised to move even earlier
in the paradigm with the LATITUDE study evaluating the value of adding Zytiga in combination with
standard androgen deprivation therapy. The ASCO presentation in the plenary session should be the first
data from LATITUDE and, if positive, could greatly expand the potential market for Zytiga.
LBA4: Lynparza for Breast Cancer (AZN)
PARP inhibitors are part of a relatively new target class, and three have already gained approval for
ovarian cancer. This presentation should include the first quantitative details from the Phase III –
OlympiAD study representing the first pivotal data for PARP inhibitors in breast cancer. It was disclosed
earlier this year that the study succeeded on its primary PFS endpoint, so the ASCO presentation should
move the therapy one step closer to becoming the first PARP inhibitor to gain approval in breast cancer.
LBA500: Perjeta for Breast Cancer (RHHBF)
Before the meeting, it was disclosed that the APHINITY study succeeded on its primary endpoint of
disease-free survival for HER2-positive metastatic breast cancer. At ASCO, quantitative details should be
presented that should move the conditional approval of this Perjeta-Hercepin-chemotherapy triple
combination to a full approval in the adjuvant setting. These details could also impact neratinib (PBYI)
which is aiming for a similar patient population. An NDA has already been filed for neratinib, and an FDA
advisory committee is scheduled to meet before ASCO.
LBA2501: Larotrectinib for Solid Tumors (LOXO)
Larotrectinib is a TRK inhibitor being developed for patients with Trk-specific mutations. Despite only
Phase I data to date, the company has already given guidance for regulatory filings potentially as soon as
late 2017. This LBA could be the first data from the pivotal NAVIGATE study and the first step towards the
company’s first approved drug.
LBA9007: Dacomitinib for NSCLC (PFE)
Dacomitinib development is on very thin ice after the failure of two second-line NSCLC trials. However,
the ARCHER 1050 study in first-line patients was continued, and ASCO should be the first look at whether
the drug has any chance to continue development.

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Biomedtracker Key Drug Analyses
Idhifa for Acute Myelogenous Leukemia (AML) (CELG)
Phase I/II - 001 (Hematologic Malignancies w/IDH2 Mutation)
Trial Data – Updated Results
Change to LOA: +1%
Abstract 7004: Enasidenib in mutant-IDH2 relapsed or refractory acute myeloid leukemia (R/R AML):
Results of a phase I dose-escalation and expansion study
Comment
The relapsed setting remains an attractive target for developers looking to gain entry into the AML
market. There is currently no standard of care for relapsed AML and late-stage pipeline candidates in the
relapsed setting are being developed for patients with adverse cytogenetics that are associated with poor
treatment outcomes. These mutations include those in the FLT3 and IDH2 genes. Considering Rydapt’s
recent FDA approval for the treatment of adult patients with newly diagnosed AML who are FLT3
mutation-positive, and as the only targeted therapy approved for the treatment of AML in the US,
positive data from enasidenib’s trials are likely to support its regulatory approval in the R/R AML setting
where it could potentially be the only therapy specifically for IDH2-mutation positive patients.
Data presented here are consistent with previously reported results and demonstrate a good level of
disease control in high-risk patients who are unable to tolerate intensive chemotherapy. For the first
time, overall survival (OS) is reported with the median OS for R/R IDH2 mutation positive patients of 9.3
months. We believe this data is promising given that in elderly AML patients ineligible for high-intensity
induction chemotherapy, Vidaza and Dacogen reported median survival of 10.4 months and 7.7 months,
respectively.
As we await a decision on the submitted NDA, which is expected by August 30th, 2017, we are increasing
the LOA by an additional 1%.
Treatment All Treatment
Treatment Description Enasidenib 100 mg/day Enasidenib
Number of Patients 109 176
ORR 38.5 % 40.3 %
CR 20.2 % 19.3 %
CR with incomplete hematologic recovery 6.8 % 6.4 %
Morphologic leukemia-free state 9.2 % 8.0 %
Partial remission 2.8 % 6.3 %
Median response duration 5.6 Months 5.8 Months
Stable disease 53.2 % 48.3 %
Design
This Phase I/II study assessed the maximum tolerated dose (MTD), pharmacokinetic and
pharmacodynamic profiles, safety, and clinical activity of enasidenib in pts with mIDH2 myeloid
malignancies. Safety for all pts and efficacy outcomes for R/R AML pts from the Phase I dose-escalation

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and expansion phases are reported.
Results
In all, 239 pts received enasidenib. In the dose-escalation (n=113), the MTD was not reached at doses up
to 650 mg daily. Median 2HG reductions from baseline were 92%, 90%, and 93% for pts receiving <100
mg, 100 mg, and >100 mg daily, respectively. Enasidenib 100 mg QD was chosen for the expansion phase
(n=126) based on PK/PD profiles and demonstrated efficacy. Median number of enasidenib cycles was 5
(range 1–25).
For R/R AML pts, overall response rate (ORR) was 40.3%, including 34 (19.3%) complete remissions (CR).
Response was associated with cellular differentiation, typically with no evidence of aplasia. Median
overall survival (OS) for R/R AML pts was 9.3 months (mos). For pts who attained CR, OS was 19.7 mos.
Pts who had received ≥2 prior AML regimens (n=94; 53%) had median OS of 8.0 mos.
Most Common Adverse Events
Grade 3-4 drug-related investigator reported AEs included indirect hyperbilirubinemia (12%) and IDH-
inhibitor-associated differentiation syndrome (ie, retinoic acid syndrome; 7%).
Conclusion
Enasidenib was well tolerated, induced CRs, and was associated with OS of >9 mos in pts who had failed
prior AML therapies. Differentiation of myeloblasts, not cytotoxicity, appears to drive the clinical efficacy
of enasidenib.
Source: American Society of Clinical Oncology (ASCO) (Abstract 7004)
Sagient Analysis
Bavencio for Bladder Cancer (MKGAY)
Phase I - JAVELIN Solid Tumor
Trial Data – Updated Results
Change to LOA: 0%
Abstract 4528: Updated efficacy and safety of avelumab in metastatic urothelial carcinoma (mUC): Pooled
analysis from 2 cohorts of the phase 1b Javelin solid tumor study
Comment
While these updated efficacy data reveal slight improvements in ORR and PFS compared with results
presented at ESMO 2016, it will unlikely be enough to differentiate the drug from other immunotherapies
in the increasingly crowded second-line bladder cancer treatment setting. Furthermore, the 7.4 months
median OS is slightly low compared with PD-1/PD-L1 inhibitors in urothelial bladder cancer, though the
small study population and absence of a comparator arm makes such cross-trial comparisons particularly
difficult. Interestingly, Banvecio does not currently appear to have a Phase III confirmatory trial for the
second-line setting. Instead, Merck is expected to pursue the maintenance setting for full regulatory
approval in urothelial bladder cancer.

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Treatment Treatment
Treatment Description Avelumab
Post-Platinum with >6 months of follow up
Avelumab
All Post-Platinum
Number of Patients 161 242
ORR 17.4 % N/A
Complete Response 6.2 % N/A
Disease Control Rate 39.8 % N/A
24-Week Durable Response Rate 92.3 % N/A
Median PFS N/A 6.6 weeks
Median OS N/A 7.4 Months
6-Month OS Rate N/A 54.9 %
Design
Patients (pts) with mUC progressed after platinum-based therapy or cisplatin ineligible received avelumab
10 mg/kg 1-hour IV Q2W. Tumors were assessed every 6 weeks by independent review (RECIST v1.1).
Endpoints
Endpoints included objective response rate (ORR), duration of response (DOR), progression-free survival
(PFS), overall survival (OS), safety (NCI CTCAE v4.0), and tumor PD-L1 expression.
Results
As of Jun 9, 2016, 249 pts had received avelumab for a median of 12 weeks (range 2-92) and were
followed up for a minimum of 6 weeks. Primary tumor site was upper tract (renal pelvis/ureter) in 23.3%
and lower tract (bladder/urethra) in 76.7%. 242 pts (97.2%) had progressed on prior platinum therapy
and 7 pts (2.8%) were platinum naive. In 161 post-platinum pts with ≥6 months of follow-up, confirmed
ORR was 17.4% (95% CI 11.9-24.1; complete response in 6.2%) with a disease control rate of 39.8%.
Response was ongoing in 23/28 responders at data cut (82.1%; median DOR not reached), and the 24-
week durable response rate was 92.3% (95% CI 72.6-98.0). Responses occurred across PD-L1 expression
levels tested (≥5% and < 5% tumor cell‒staining [25.4% and 13.2%]). In all post-platinum pts (n = 242),
median PFS was 6.6 weeks (95% CI 6.1-11.6), median OS was 7.4 months (95% CI 5.7-10.3) and 6-month
OS rate was 54.9 (95% CI 47.7-61.7).
Most Common Adverse Events
Treatment-related adverse events (TRAE) of any grade occurred in 166/249 pts (66.7%); most common
(≥10%) were infusion-related reaction (22.9%, all grade ≤2) and fatigue (16.1%). 21 pts (8.4%) had a grade
≥3 TRAE (fatigue [1.6%] and asthenia [0.8%] in > 1 pt). 34 pts (13.7%) had an immune-related AE (grade
≥3 in 2.4%). There was 1 treatment-related death (pneumonitis).
Conclusion
Avelumab was well tolerated and showed durable responses in heavily pretreated pts with mUC,
irrespective of tumor PD-L1 expression status.
Source: American Society of Clinical Oncology (ASCO) (Abstract 4528)
Sagient Analysis