prIME LINES October 2015

TABLE OF CONTENTS

• PHARMA NEWS

• CONFERNECE NEWS FROM THE 2015 EUROPEAN CANCER CONGRESS

• UPCOMING prIME EVENTS

• OTHER prIME ACTIVITES

prIME Lines – October 2015 Issue

PHARMA NEWS

TAS-102 Approved for Refractory Colorectal Cancer

On 22 September 2015, the U.S. Food and Drug Administration (FDA) approved

TAS-102 (Lonsurf®, Taiho Pharmaceutical), for the treatment of patients with refractory

metastatic colorectal cancer (mCRC) who had previously received at least two standard

therapies including chemotherapy, bevacizumab, and, if RAS wildtype, one of the anti-

epidermal growth factor receptor (EGFR) monoclonal antibody, cetuximab or

panitumumab. This novel combination of trifluridine, a nucleoside analogue that inhibits

DNA synthesis, and tipiracil, which inhibits thymidine phosphorylase and helps maintain

blood levels of trifluridine, was shown to significantly improve overall survival (OS)

compared to placebo in a randomized phase III trial of 800 patients with mCRC. Most

patients were heavily pretreated and received more than 4 lines of therapy, including

targeted agents. Median OS was 7.1 months with TAS-102 compared to 5.3 months in

the placebo group (hazard ratio [HR] = 0.68; P<.001). TAS-102 was well tolerated and

the neutropenia was the most common grade 3/4 adverse event (38%). These results were

published in the 14 May 2015 issue of the New England Journal of Medicine.

Ipilimumab/Nivolumab Combination, a New Standard of Care for Advanced

Melanoma

On 30 September 2015, the FDA granted accelerated approval to the combination of

ipilimumab and nivolumab (Yervoy® and Opdivo®, Bristol-Myers Squibb) for the

treatment of BRAF V600 wildtype, unresectable, or metastatic melanoma. This is the first

FDA approval of a combination of two immune checkpoint inhibitors, both of which are

currently approved as single-agent therapy for melanoma. The decision was based on

results from the CheckMate 069 trial, a randomized, double-blind, phase II study that

compared ipilimumab plus nivolumab to ipilimumab alone in 140 treatment-naïve

patients. The combination significantly increased the confirmed objective response rate

(ORR, 60% vs 11%; P<.001) and prolonged median progression-free survival (PFS) by

approximately 4 months compared to ipilimumab alone (8.9 months vs 4.7 months;

HR = 0.40; P<.002). However, the combination was associated with a higher rate of

severe adverse events (62% vs 39%), and the expected price tag (approximately $256,000

in the first year) is again raising concerns about the high cost of cancer therapy.

Two PD-1 Inhibitors Now Approved in the United States for Advanced NSCLC

On 2 October 2015, the FDA granted accelerated approval to pembrolizumab

(Keytruda®, Merck) for patients with programmed cell death ligand 1 (PD-L1)-positive,

metastatic, non-small-cell lung cancer (NSCLC) whose disease has progressed after other

treatments, including platinum-containing chemotherapy or EGFR-targeted and ALK-

targeted agents. This decision was based on data from a subset of 61 patients with high

PD-L1–expressing disease in the large multicenter KEYNOTE-1 trial (N = 550)

investigating pembrolizumab in NSCLC regardless of histology. The ORR in this subset

was 41%, and the duration of response ranged from 2 months to 9 months.

Pembrolizumab is now the second programmed cell death 1 (PD-1) inhibitor approved

for lung cancer, and it was approved along with the PD-L1 immunohistochemistry (IHC)

22C3 pharmDx companion diagnostic, the first approved test designed to detect PD-L1

expression in NSCLC.

On a related note, on 9 October, the FDA expanded the label for nivolumab (Opdivo®,

Bristol-Myers Squibb) to include previously treated advanced nonsquamous NSCLC (it

was approved for squamous histology earlier this year). Clearly the efficacy of these

agents is not limited to a single histology. This extended indication for nivolumab is

based on results from the phase III CheckMate 057 trial in which second-line treatment

with nivolumab reduced the risk of death by 27% compared to docetaxel in patients with

nonsquamous NSCLC. Furthermore, in patients with the highest PD-L1 expression, the

risk reduction was 61%. The FDA also approved the complementary diagnostic test (PD-

L1 IHC 28-8 pharmDx) that was used in the CheckMate 057 for PD-L1 assessment. This

means that testing for PD-L1 is not mandatory for nivolumab use in NSCLC, but may

provide clinicians with additional information. In contrast, for pembrolizumab,

assessment of PD-L1 expression with companion diagnostic test is essential for effective

use of the drug.

Second Combination of MET and BRAF inhibitors Gets Green Light in Europe

On 24 September 2015, the European Medical Agency (EMA) recommended approval of

the MEK inhibitor cobimetinib (Cotellic™, Exelixis/Roche) in combination with BRAF

inhibitor vemurafenib (Zelboraf®, Genentech) for the treatment of unresectable or

metastatic BRAF V600–mutant melanoma. This decision was based on results from

coBRIM, a randomized, phase III, double-blind, placebo-controlled study comparing the

combination with vemurafenib alone in 495 patients. The combination, which is thought

to reduce development of resistance to BRAF inhibition, significantly improved PFS by

investigator assessment (median 9.9 months vs 6.2 months; HR = 0.51; P<.0001) and the

ORR (68% vs 45%; P<.0001) compared with vemurafenib alone. This combination is not

yet approved in the United States (US). However, another combination of MEK/BRAF

inhibitors (trametinib/dabrafenib) is approved both in Europe and in the US.

Additional EMA Positive Opinions in Line With FDA Approvals

On 24 September 2015, several months after FDA approvals, the EMA adopted positive

opinions for:

• Blinatumomab (Blincyto®, Amgen) for the treatment of adult Philadelphia

chromosome–negative, relapsed or refractory, B-precursor, acute lymphoblastic

leukemia

• Carfilzomib (Kyprolis®, Amgen) for use in combination with lenalidomide and

dexamethasone for the treatment of adult patients with multiple myeloma who

have received at least one prior therapy

• Nivolumab (Opdivo®, Bristol-Myers Squibb) for the treatment of locally

advanced or metastatic squamous NSCLC after prior chemotherapy

CONFERENCE NEWS FROM THE 2015 EUROPEAN CANCER CONGRESS

The 2015 European Cancer Congress (ECC), which is one of the largest European

platform for presenting ground-breaking data to a global audience, was convened in

Vienna, Austria, 25-29 September. More than 17,000 delegates around the world

attended the sessions highlighting data from more than 2000 abstracts, including an

impressive number of late-breaking abstracts. The 2015 congress had a twin focus on

“multidisciplinarity” and the interlinking of laboratory and clinical research. This

newsletter is dedicated to summaries of some of the most compelling abstracts presented

at ECC this year. In particular, immunotherapy with anti-PD-1/PD-L1 antibodies

continues to show meaningful benefit in melanoma, lung cancer, and renal cell cancer

(RCC). In addition, PD-1 blockade seems to be promising treatment strategy in several

rare cancers including anal cancer, nasopharyngeal cancer, and Merkel cell carcinoma,

where treatment options are limited.

Breast Cancer

TAILORx Confirms That Oncotype DX Low-Risk Breast Cancer Patients Don’t

Need Chemotherapy

Results of the TAILORx low-risk registry, the first prospective test of the 21-gene

recurrence score (RS) assay, showed that endocrine therapy alone is sufficient for women

with hormone-receptor (HR)–positive early breast cancer who have a low RS (range, 0 to

10). This abstract, presented by Joseph Sparano, MD (Montefiore Medical Center, Bronx,

New York, Untied States), received the Best Abstract distinction. The TAILORx study

enrolled 10,253 women with HR-positive, HER2-negative, node-negative, early breast

cancer. Of those, 15.9% had a low RS (defined as ≤10) and were eligible to receive an

aromatase inhibitor, tamoxifen, or a sequence of the two for 5 years, without

chemotherapy. In the low-risk group, the rate of invasive disease-free survival (DFS) at 5

years was 93.8%. In addition, 98.7% of women were free from any recurrence at 5 years,

and 99.3% were free from distant metastatic recurrence. The 5-year OS rate was 98.0%.

These results were simultaneously published in the New England Journal of Medicine.

Discussant Cliff Hudis, MD (Memorial Sloan Kettering Cancer Center) commented that

these patients would not derive any meaningful benefit from the addition of

chemotherapy, based on the almost complete absence of metastatic spread at 5 years. He

further commented that the results provide "confirmation" that the 21-gene recurrence

score assay, which has been used by clinicians for about 10 years, can identify a cohort of

patients who can be spared chemotherapy. However, he expressed concern that the study

a different definition of low-risk score compared with what is commonly used in clinical

practice (RS <18), which may cause some confusion.

Eur J Cancer. 2015;5(Suppl 3): Abstract 5BA.

Gastrointestinal Malignancies

Defining the Benefit of EGFR Inhibitors in Metastatic Colorectal Cancer With a

KRAS G13D Mutation

Preliminary results from the ICECREAM trial suggest that cetuximab monotherapy is not

effective in patients with KRAS G13D-mutated mCRC, but the combination of cetuximab

and irinotecan achieved objective responses and delayed disease progression in patients

who were refractory to irinotecan. This randomized phase II study, conducted by the

Australasian Gastro-Intestinal Trials Group, is seeking to better define the activity of

EGFR inhibitors in mCRC with the G13D mutation in exon 2. Preclinical models and

retrospective clinical reports have suggested that cetuximab may have activity in these

tumors similar to that seen in KRAS wildtype mCRC. The study is enrolling patients who

are refractory to irinotecan (progression within 6 months) and intolerant or refractory to

fluoropyrimidine and oxaliplatin. Patients are randomized to treatment with cetuximab or

cetuximab + irinotecan. Eligible patients are also stratified based on G13D mutation or no

mutations in KRAS, NRAS, BRAF, and PI3KCA (the later cohort is still recruiting). Data

on 53 patients enrolled in the G13D cohort demonstrated a 6-month PFS rate of 23% with

cetuximab + irinotecan versus 10% with cetuximab monotherapy (HR = 0.75), and the

combination induced a 9% partial response (PR) rate compared with no objective

responses in the cetuximab group. Based on these findings, the authors concluded that

cetuximab monotherapy is not active in patients with G13D-mutated mCRC, but further

investigation is warranted to determine if cetuximab + irinotecan has additive or

synergistic antitumor activity in this setting, and they stressed the importance of

international collaboration to recruit rare molecular subtypes in clinical trials.

Eur J Cancer. 2015;5(Suppl 3): Abstract 32LBA.

For information on abstracts in HR-positive metastatic breast cancer presented in Vienna, please visit

prIME Oncology’s Clinical Spotlight on Breast Cancer.

Neuroendocrine Tumors

RADIANT-4 and NETTER-1Trials: Impressive PFS Improvement in Patients with

Advanced Neuroendocrine Tumors

Two late-breaking abstracts on neuroendocrine tumors (NETs) were presented at the

second Presidential Session: 5LBA reported on the RADIANT-4 trial of everolimus;

6LBA reported on the NETTER-1 trial of 177-Lu-Dotatate (a radiolabeled somatostatin

analogue [SSA]).

Results of the randomized, phase III, placebo-controlled RADIANT-4 trial demonstrated

that everolimus (10 mg/day) significantly improved PFS compared with placebo in

patients with advanced, nonfunctional NET of lung or gastrointestinal origin. Median

PFS by central review was 11.0 months in the everolimus arm and 3.9 months in the

placebo arm (HR = 0.48; P<.001). Moreover, a preplanned interim OS analysis showed a

nonsignificant trend in favor of everolimus (HR = 0.64; P = .037). Presenter James Yao,

MD (University of Texas, MD Anderson Cancer Center, Houston, Texas, United States),

concluded that the observed 7-month improvement in median PFS is clinically

meaningful, and that everolimus was well tolerated. This is particularly relevant for lung

NETs, which is an area of significant unmet medical need. Although everolimus is

approved for the treatment of pancreatic NETs, this is the first time it has been shown to

be effective in NETs from other sites of origin. Discussant Enrique Grande, MD (Ramón

y Cajal University Hospital, Madrid, Spain), pointed out that everolimus is the first drug

shown to have significant activity in lung NETs in a randomized, controlled trial.

For more information on abstracts in colorectal cancer presented in Vienna, please visit prIME Oncology’s Clinical Spotlight in Colorectal Cancer

and Virtual Poster Session.

Results of another randomized, phase III trial (NETTER-1) in patients with inoperable,

progressive, somatostatin receptor–positive midgut NETs showed that peptide receptor

radionuclide therapy (PRRT) with 177Lu-DOTA0-Tyr3-Octreotate (177-Lu-Dotatate)

significantly improved PFS compared with octreotide LAR (60 mg). Median PFS was not

reached in the 177-Lu-Dotatate arm compared with 8.4 months in the octreotide arm

(HR = 0.21; P<.0001). Discussant Enrique Grande, MD, hailed these results as “the most

impressive PFS we have ever seen” in patients with midgut NETs that had progressed on

first-line SSA therapy, but he cautioned that long-term safety data are needed, especially

in view of the cytopenias that were reported. Taken together with the outcomes of

RADIANT-4, he suggested that there is now a stronger rationale for using single-agent

everolimus after failure of an SSA regardless of tumor origin, but that PRRT may

become standard after SSA failure for patients with midgut NETs.

Eur J Cancer. 2015;5(Suppl 3): Abstract 5LBA.

Eur J Cancer. 2015;5(Suppl 3): Abstract 6LBA.

Lung Cancer

Immune Checkpoint Inhibitors Continue to Make Headlines in NSCLC

Immune checkpoint inhibitors atezolizumab and pembrolizumab both showed impressive

efficacy and good tolerability in patients with NSCLC, and pembrolizumab just received

accelerated approval for pretreated NSCLC based on data from the KEYNOTE-1 trial

(see Pharma News above), thus becoming the second PD-1 inhibitor approved for this

indication. These agents are effective regardless of histology, and they are most effective

against the subset of tumors that express high levels of PD-L1. Immune checkpoint

inhibitors are positioned to shake up the treatment paradigm for advanced lung cancer.

For an expert opinion on these two trials, please visit prIME Oncology’s Clinical Spotlight on the Management of NET from Vienna.

• Results of the phase II, single-arm, BIRCH trial (N = 659) demonstrated that

anti-PD-L1 antibody atezolizumab (1200 mg every 3 weeks) has similar activity

in PD-L1−selected patients when used as either first-line, second-line, or third-

line therapy (Abstract 16LBA). Among patients with the highest level of PD-L1

expression in their tumor cells, the ORR by RECIST was approximately 25%

regardless of the line of therapy, and the 6-month PFS rate was 48% for first-line

patients, 34% for second-line patients, and 39% for third-line patients. Discussant

Luis Paz-Ares, MD, PhD (Hospital Universitario Doce de Octubre, Madrid,

Spain), pointed out that these data are consistent with those reported from other

trials, including the POPLAR trial of atezolizumab in the second-line and third-

line setting and the CheckMate 012 trial of nivolumab in the first-line setting. The

question that remains is whether patients benefit more from these agents when

used in the first-line setting.

• Meanwhile, primary results of the randomized, phase II, POPLAR trial (N = 287)

in the second or third-line setting demonstrated that atezolizumab significantly

improved OS compared to docetaxel in unselected NSCLC patients (median 12.6

months vs 9.7 months; HR = 0.73; P = .04), but only those with PD-L1-

expression on tumor cells or immune cells received any benefit (Abstract

14LBA). The subset with the highest PD-L1 expression had the greatest

improvement in OS (median 15.5 months vs 11.1 months; HR = 0.49). A phase

III confirmatory trial is ongoing.

• Finally, the KEYNOTE-001 investigators reported the efficacy and safety of

pembrolizumab (2 mg/kg every 2 weeks or 10 mg/kg every 2 or 3 weeks) in 449

patients with previously treated NSCLC. Similar to the findings with

atezolizumab, the subset of 124 patients with tumors expressing high levels of

PD-L1 had the best response. In this subset, the ORR by RECIST was 35.5%

compared with only 18.7% in the overall study population, median duration of

response (DOR) was 23.3 months, median PFS was 5.8 months, and median OS

was 14.0months.

Eur J Cancer. 2015;5(Suppl 3): Abstract 16LBA.

Eur J Cancer. 2015;5(Suppl 3): Abstract 14LBA.

Eur J Cancer. 2015;5(Suppl 3): Abstract 33LBA.

Erlotinib/Bevacizumab Combination Highly Active in NSCLC Patients With

T709M Mutation

In the open-label, phase II BELIEF trial, the front-line combination of bevacizumab and

erlotinib was highly effective in patients with advanced NSCLC harboring an EGFR

T709M mutation, which is believe to be the main mechanism of acquired resistance to

EGFR tyrosine kinase inhibitors (TKIs) and this mutation may also be detected before

initial treatment. This cooperative group study enrolled 109 patients with advanced

NSCLC and centrally confirmed activating EGFR (exon 19 or L858R mutations).

Pretreatment T790M mutations (found in 37 [34%] patients) were identified by laser

microdissection and TaqMan mutation detection assay. In the whole patient group, the

combination of erlotinib and bevacizumab resulted in a 1-year PFS of 56.7% and median

PFS of 13.8 months. Among patients with a T790M mutation, the 1-year PFS rate was

72.4%, and median PFS was 16.0 months. The toxicity of combination therapy was

consistent with previous reports. Martin Reck, MD, PhD (Hospital Grosshansdorf,

Grosshansdorf, Germany) in his discussion explained the rationale for using this

combination approach, but according to his opinion these results will probably not impact

practice directly. He pointed out a need for a randomized confirmation, particularly the

comparison with a third generation EGFR-TKI would be of interest.

Eur J Cancer. 2015;5(Suppl 3): Abstract 3BA.

For more detailed results of these studies, please visit prIME Oncology’s Virtual Poster Session on Immuno-Oncology from Vienna.

Delta-Like Protein 3 (DLL3)-Targeted Antibody Drug Conjugate Is Active in Small

Cell Lung Cancer

A first-in-human, phase I study of the DLL3-targeted antibody drug conjugate,

rovalpituzumab tesirine (Rova-T; Stemcentrx Inc), showed promising antitumor activity

in patients with recurrent, DLL3-positive, small-cell lung cancer (SCLC) treated with the

phase Ib expansion dose of 0.2 mg every 3 weeks or 0.3 mg every 6 weeks. This phase I,

dose-escalation study enrolled 79 patients, of whom 45% had received 2 prior therapies,

and 53 patients in the phase Ib expansion cohort were evaluable for response. The ORR

was 24%. Among 49 evaluable tumor specimens (~70%) that exhibited high DLL3

expression, and among 27 patients with confirmed DLL3-positive tumors, the ORR was

44% in the second-line setting and 45% in the third-line setting where no standard

therapy currently exists. Discussant Martin Reck, MD, PhD (Hospital Grosshansdorf,

Grosshansdorf, Germany), commented that this may become the first targeted therapy for

SCLC based on the observed activity, which so far appears better than that of topotecan

in the second-line setting. But more data are needed, and the optimal treatment setting

remains to be determined.

Eur J Cancer. 2015;5(Suppl 3): Abstract 7LBA.

Genitourinary Malignancies

Nivolumab and Cabozantinib Challenge Everolimus for Second-Line Treatment of

Advanced RCC

Two phase III trials—CheckMate 025 and METEOR—that pitted nivolumab or

cabozantinib, respectively, against everolimus, the current standard of care for second-

line treatment of advanced RCC, will likely change the treatment landscape for patients

who progress on vascular endothelial growth factor receptor (VEGFR)-targeted therapy.

Both agents were superior to everolimus. These two late-breaking abstracts were

presented in the first Presidential Session and were simultaneously published in the New

England Journal of Medicine (CheckMate 025; METEOR)

• In the CheckMate 025 trial (N = 821), nivolumab (3 mg/kg) demonstrated a

statistically significant and clinically meaningful OS benefit compared to

everolimus (10 mg/day), a higher ORR (25% vs 5%), and a lower incidence of

high-grade treatment-related adverse events (19% vs 37%). Median OS was

25.0 months on nivolumab compared with 19.6 months on everolimus

(HR = 0.73; P = .002). This is the first time an OS benefit has been demonstrated

in the second-line setting.

• In the METEOR trial (N = 658), 60 mg/day cabozantinib doubled median PFS

compared with 10 mg/day everolimus (median 7.4 months vs 3.8 months;

HR = 0.58; P<.001). Cabozantinib inhibits multiple receptor tyrosine kinases

including MET, VEGFRs, and AXL. The ORR was 21% with cabozantinib and

5% with everolimus (P<.001). Survival data are not yet mature, however, a

planned interim analysis demonstrated a trend for survival improvement with

cabozantinib (HR = 0.67; P = .005), but prespecified interim boundary for

statistical significance was not reached. Of note, 60% of patients in the

cabozantinib arm required dose reduction due to adverse events compared with

25% of patients in the everolimus arm, but the rate of discontinuation due to

adverse events was similar in both arms.

Discussant Cora Sternberg, MD, FACP (San Camillo and Forlanini Hospital, Rome,

Italy), pointed out that 7 new agents have been approved for advanced metastatic RCC in

the past decade based on improvements in PFS, but none have shown an OS benefit. The

25-month median OS observed in the CheckMate 025 trial sets a new benchmark, and it

seems likely that cabozantinib may also show an OS benefit when the data are mature.

But many questions remain, and there is an urgent need for biomarkers that can predict

response. After a decade of focusing on targeted therapies directed at VEGFR and

mTOR, these studies show that immunotherapy (once the only effective therapy) and

novel agents that target resistance to VEGFR-targeted agents need to be integrated into

the treatment of this disease.

Eur J Cancer. 2015;5(Suppl 3): Abstract 3LBA.

Eur J Cancer. 2015;5(Suppl 3): Abstract 4LBA.

Promising Activity of Atezolizumab in Recurrent Metastatic Bladder Cancer

Results from a pivotal multicenter phase II study (IMvigor 210) showed that anti-PD-L1

antibody atezolizumab produces durable responses in heavily pretreated patients with

locally-advanced or metastatic urothelial carcinoma, a poor prognosis population. All 311

patients had received prior platinum-based chemotherapy, and 40% had received at least

2 prior regimens for metastatic disease. In the overall study population, the ORR was

15% by RECIST, and among 100 patients with medium and high PD-L1 expression on

tumor-infiltrating immune cells, the ORR was 27% (8% complete response), PFS was 2.1

months and median OS has not yet been reached. Atezolizumab was well tolerated with

only 4% of immune-related grade 3/4 toxicities and importantly, with no treatment-

related renal toxicity. Authors concluded that, based on these data, atezolizumab has the

potential to change the standard of care in metastatic urothelial carcinoma. Discussant

Ronald de Wit, MD, PhD (Erasmus University, Daniel den Hoed Cancer Center,

Rotterdam, the Netherlands), pointed out that efficacy data compares favorably to

historical data with cytotoxic agents and TKIs. He concluded that these data are

promising, but we need to await the results of ongoing phase III trials, and the biomarker

needs to be better defined.

Eur J Cancer. 2015;5(Suppl 3): Abstract 21LBA.

Melanoma

Sequence of Immune Checkpoint Inhibitors May Impact Efficacy in Melanoma

Results of the randomized, open-label, phase II CheckMate 064 trial showed improved

ORR with nivolumab followed by ipilimumab versus ipilimumab followed by nivolumab

in patients with advanced melanoma. Patients with unresectable stage III or IV melanoma

who were either treatment-naïve or had received one prior systemic therapy were

randomized to sequential induction with nivolumab (3 mg/kg every 2 weeks x 6 doses)

followed by IPI (3 mg/kg every 3 weeks x 4 doses) (cohort A; N = 68) or ipilimumab

followed by nivolumab (cohort B; N = 70). Patients in cohort A had an ORR of 41.2%

and 6-month progression rate of 38% compared with 20.0% ORR and 60% progression

rate in cohort B. The safety profile was similar regardless of the sequence. The authors

concluded that further data from this study may inform the choice of treatment regimens

in advanced melanoma.

Eur J Cancer. 2015;5(Suppl 3): Abstract 23LBA.

Sarcoma

Impressive Survival Benefit of Regional Hypothermia in Localized, High-Risk, Soft

Tissue Sarcoma

Long-term outcomes of the EORTC 62961/ESHO randomized phase III trial showed that

adding regional hypothermia (RHT) to standard neoadjuvant/adjuvant chemotherapy for

operable, high-risk soft tissue sarcoma (STS) significantly improved local PFS, DFS, and

OS compared with chemotherapy alone. Median OS was 15.4 years for chemotherapy +

RHT and 6.2 years for chemotherapy alone (HR = 0.74; P = .047). The authors concluded

that these findings provide strong support to use regional hyperthermia as a new standard

treatment in patients with high risk operable STS. Discussant Jean Yves Blay, MD

(Université Claude Bernard, Lyon, France), commented that RHT clearly has a role in

this setting and needs to be evaluated further. He noted that the ORR strongly favored the

RHT group (30.6% vs 13.8%; P = 0.002) and that survival curves suggest increase cure

rate in high-risk patients. However, to fully understand results of this important study, it

would be valuable to have information on quality of resection, metastasis-free survival,

patterns of relapse, and treatment at relapse. Additionally, he mentioned that comparator

arm in the study was not a universal standard treatment and that confirmatory trial is

warranted.

Eur J Cancer. 2015;5(Suppl 3): Abstract 13LBA.

UPCOMING prIME EVENTS

14 November 2015 Miami, Florida, United States 21 November 2015 | Chicago, Illinois, United States 3 November 2015 | Winston-Salem, North Carolina, United States 4 November 2015 | New York, New York, United States 4 November 2015 | South Bend, Indiana, United States 5 November 2015 | Boise, Idaho, United States 5 November 2015 | Tampa, Florida, United States 10 November 2015 | Cleveland, Ohio, United States 24 November 2015 | Columbus, Ohio, United States

5 November 2015 | New York, New York, United States

7 November 2015 | St Louis, Missouri, United States 11 November 2015 | Granger, Indiana, United States

19 November 2015 | San Antonio, Texas, United States

20 November 2015 | San Antonio, Texas, United States 21 November 2015 | San Antonio, Texas, United States

OTHER prIME ACTIVITIES

Oncology Guru: Test Your Knowledge in Oncology/Hematology

Expert Review in Lung Cancer: Optimizing the Treatment Paradigm for Patients With ALK-Positive Non-Small Cell Lung Cancer

Downloadable Slides From New Therapeutic Strategies for Glioblastoma in 2015

Symposium Webcast—Building on the Foundation of Proteasome Inhibition in Multiple Myeloma

The Role of Disparities in Cancer Care Downloadable Slides From Endocrine Therapies in Breast and Prostate Cancers: Important Considerations for Patient Management in 2015

Virtual Poster Session—Practical Application of Key Data Presented During the 2015 European Oncology Congress in Vienna Clinical Spotlight in Hormone Receptor–Positive Metastatic Breast Cancer

Clinical Spotlight in Colorectal Cancer From the 2015 European Oncology Congress in Vienna

Clinical Spotlight in the Management of Neuroendocrine Tumors: Updates from the 2015 European Oncology Congress in Vienna