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Rothschedl, E.

Nachtnebel, A.

Horizon Scanning in Oncology    
 
 
Seite 1 von 7 
Priorisierung XXIII – HSS Onkologie 
 
 
 
Horizon Scanning in Oncology 
23
rd
 Prioritization –  2nd  quarter 2015 
 
General Information, efficacy and safety 
data 
 
 
 
 
 
 
Eleen Rothschedl 
Anna Nachtnebel 
 
 
 
  
   
 
Ergänzende Informationen zu den Arzneistoffen für Priorisierung XXI – HSS Onkologie                                 Seite 2 von 7 
 
Introduction 
As part of the project „Horizon Scanning in Oncology“ (further information can be found here: 
http://hta.lbg.ac.at/page/horizon-scanning-in-der-onkologie), 9 information sources are scanned 
frequently to identify emerging anticancer drugs. 
Every 3 months, these anticancer therapies are filtered (i.e. in most cases defined as availability of 
phase III results; for orphan drugs also phase II) to identify drugs at/around the same time as the 
accompanying drug licensing decisions of the EMA.  
An expert panel consisting of oncologists and pharmacists then applies 5 prioritisation criteria to elicit 
those anti-cancer therapies which might be associated with either a considerable impact on financial 
resources or a substantial health benefit.  
For the 23
rd
 prioritisation (June 2015), 10 drugs were filtered out of 170 identified and were sent to 
prioritisation. Of these, 4 drugs were ranked as ‘highly relevant’ by the expert panel, 5 as ‘relevant’ and 
1 as ‘not relevant’. For ‘highly relevant’ drugs, further information including, for example, abstracts of 
phase III studies and licensing status is contained in this document. 
The summary judgements of the expert panel for all prioritised drugs are provided in the following 
table. 
 
No  Filtered Drugs – 23rd prioritisation 2nd quarter 2015 
 
Overall category 
1. Afatinib (BIBW-2992, Gilotrif®, Giotrif®) as second-line treatment 
in patients with recurrent or metastatic squamous-cell carcinoma 
of the head and neck 
Relevant 
2. Neoadjuvant bevacizumab (Avastin®) for women with HER2-
negative early breast cancer 
Relevant 
3. Cisplatin plus gemcitabine as first-line therapy for metastatic 
triple-negative breast cancer 
Not relevant 
4.. Ramucirumab (Cyramza®, IMC-1121B) in combination with 
FOLFIRI as second-line therapy for metastatic colorectal 
carcinoma 
Highly relevant 
5. TAS-102 (= trifluridine and tipiracil hydrochloride) for refractory 
metastatic colorectal cancer 
Relevant 
6. Elotuzumab (BMS 901608, HuLuc63) for relapsed or refractory 
multiple myeloma 
Relevant 
7. Ipilimumab (Yervoy®, MDX-010) as adjuvant therapy for high risk 
stage III melanoma 
Highly relevant 
8. Nivolumab (BMS-936558 / MDX1106 / ONO4538 ) as second-line 
therapy for  advanced melanoma 
Highly relevant 
9. Pembrolizumab (Keytruda®, MK-3475) in advanced melanoma Highly relevant 
10. Talimogene laherparepvec (T-VEC, OncoVEXGM-CSF) in patients 
with advanced melanoma 
Relevant 
 
 
   
 
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1 Colorectal cancer 
1.1 Ramucirumab (Cyramza®, IMC-1121B) in combination with 
FOLFIRI as second-line therapy for metastatic colorectal 
carcinoma 
 
Drug Description 
 
a human vascular endothelial growth factor receptor 2-antagonist  
 
Incidence in 
Austria 
4,577 newly diagnosed/year (2011), 28.4/100,000/year 
Approval 
status for 
this 
indication 
EMA - 
FDA 
 
04/2015: indicated in combination with FOLFIRI for the treatment of 
metastatic colorectal cancer with disease progression on or after prior 
therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine.  
 
 
Phase III results: 
Tabernero et al. Ramucirumab versus placebo in combination with second-line FOLFIRI in 
patients with metastatic colorectal carcinoma that progressed during or after first-line therapy 
with bevacizumab, oxaliplatin, and a fluoropyrimidine (RAISE): a randomised, double-blind, 
multicentre, phase 3 study. Lancet (2015) 16: 499–508. 
Background  
Angiogenesis is an important therapeutic target in colorectal carcinoma. Ramucirumab is a human 
IgG-1 monoclonal antibody that targets the extracellular domain of VEGF receptor 2. We assessed the 
efficacy and safety of ramucirumab versus placebo in combination with second-line FOLFIRI 
(leucovorin, fluorouracil, and irinotecan) for metastatic colorectal cancer in patients with disease 
progression during or after first-line therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine. 
 
Methods  
Between Dec 14, 2010, and Aug 23, 2013, we enrolled patients into the multicentre, randomised, 
double-blind, phase 3 RAISE trial. Eligible patients had disease progression during or within 6 months 
of the last dose of first-line therapy. Patients were randomised (1:1) via a centralised, interactive voice-
response system to receive 8 mg/kg intravenous ramucirumab plus FOLFIRI or matching placebo plus 
FOLFIRI every 2 weeks until disease progression, unacceptable toxic effects, or death. Randomisation 
was stratified by region, KRAS mutation status, and time to disease progression after starting first-line 
treatment. The primary endpoint was overall survival in the intention-to-treat population. This study is 
registered with ClinicalTrials.gov, number NCT01183780. 
 
Results  
We enrolled 1072 patients (536 in each group). Median overall survival was 13·3 months (95% CI 
12·4–14·5) for patients in the ramucirumab group versus 11·7 months (10·8–12·7) for the placebo 
group (hazard ratio 0·844 95% CI 0·730–0·976; log-rank p=0·0219). Survival benefit was consistent 
across subgroups of patients who received ramucirumab plus FOLFIRI. Grade 3 or worse adverse 
events seen in more than 5% of patients were neutropenia (203 [38%] of 529 patients in the 
ramucirumab group vs. 123 [23%] of 528 in the placebo group, with febrile neutropenia incidence of 18 
[3%] vs. 13 [2%]), hypertension (59 [11%] vs. 15 [3%]), diarrhoea (57 [11%] vs. 51 [10%]), and fatigue 
(61 [12%] vs. 41 [8%]). 
 
 
   
 
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Conclusion 
Ramucirumab plus FOLFIRI significantly improved overall survival compared with placebo plus 
FOLFIRI as second-line treatment for patients with metastatic colorectal carcinoma. No unexpected 
adverse events were identified and toxic effects were manageable. 
 
2 Skin cancer 
 
2.1 Ipilimumab (Yervoy®, MDX-010) as adjuvant therapy for high 
risk stage III melanoma 
 
Drug Description 
 
a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody  
 
Incidence in 
Austria 
1,551 newly diagnosed per year (2011), 12.2/100,000/year 
Approval 
status for 
this 
indication 
EMA - 
FDA - 
 
Phase III results: 
Eggermont et al. Adjuvant ipilimumab versus placebo after complete resection of high-risk 
stage III melanoma (EORTC 18071): a randomised, double-blind, phase 3 trial. Lancet (2015), 
Issue 16: 522-530. 
Background  
Ipilimumab is an approved treatment for patients with advanced melanoma. We aimed to assess 
ipilimumab as adjuvant therapy for patients with completely resected stage III melanoma at high risk of 
recurrence. 
 
Methods  
We did a double-blind, phase 3 trial in patients with stage III cutaneous melanoma (excluding lymph 
node metastasis ≤1 mm or in-transit metastasis) with adequate resection of lymph nodes (ie, the 
primary cutaneous melanoma must have been completely excised with adequate surgical margins) 
who had not received previous systemic therapy for melanoma from 91 hospitals located in 19 
countries. Patients were randomly assigned (1:1), centrally by an interactive voice response system, to 
receive intravenous infusions of 10 mg/kg ipilimumab or placebo every 3 weeks for four doses, then 
every 3 months for up to 3 years. Using a minimisation technique, randomisation was stratified by 
disease stage and geographical region. The primary endpoint was recurrence-free survival, assessed 
by an independent review committee, and analysed by intention to treat. Enrollment is complete but 
the study is ongoing for follow-up for analysis of secondary endpoints. This trial is registered with 
EudraCT, number 2007-001974-10, and ClinicalTrials.gov, number NCT00636168. 
 
Results  
Between July 10, 2008, and Aug 1, 2011, 951 patients were randomly assigned to ipilimumab (n=475) 
or placebo (n=476), all of whom were included in the intention-to-treat analyses. At a median follow-up 
of 2・74 years (IQR 2・28–3・22), there were 528 recurrence-free survival events (234 in the 
ipilimumab group vs. 294 in the placebo group). Median recurrence-free survival was 26・1 months 
(95% CI 19・3–39・3) in the ipilimumab group versus 17・1 months (95% CI 13・4–21・6) in the 
   
 
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placebo group (hazard ratio 0・75; 95% CI 0・64–0・90; p=0・0013); 3-year recurrence-free survival 
was 46・5% (95% CI 41・5–51・3) in the ipilimumab group versus 34・8% (30・1–39・5) in the 
placebo group. The most common grade 3–4 immune-related adverse events in the ipilimumab group 
were gastrointestinal (75 [16%] vs. four [<1%] in the placebo group), hepatic (50 [11%] vs. one [<1%]), 
and endocrine (40 [8%] vs. none). Adverse events led to discontinuation of treatment in 245 (52%) of 
471 patients who started ipilimumab (182 [39%] during the initial treatment period of four doses). Five 
patients (1%) died due to drug-related adverse events. Five (1%) participants died because of drug-
related adverse events in the ipilimumab group; three patients died because of colitis (two with 
gastrointestinal perforation), one patient because of myocarditis, and one patient because of 
multiorgan failure with Guillain-Barre syndrome. 
 
Conclusion 
Adjuvant ipilimumab significantly improved recurrence-free survival for patients with completely 
resected high-risk stage III melanoma. The adverse event profile was consistent with that observed in 
advanced melanoma, but at higher incidences in particular for endocrinopathies. The risk–benefit ratio 
of adjuvant ipilimumab at this dose and schedule requires additional assessment based on distant 
metastasis-free survival and overall survival endpoints to define its definitive value. 
 
2.2 Nivolumab (BMS-936558 / MDX1106 / ONO4538 ) as second-line 
therapy for  advanced melanoma 
 
Drug Description 
 
a programmed death receptor-1 (PD-1) blocking antibody 
 
Incidence in 
Austria 
1,551 newly diagnosed per year (2011), 12.2/100,000/year 
Approval 
status for 
this 
indication 
EMA 
 
06/2015: as monotherapy is indicated for the treatment of advanced 
(unresectable or metastatic)  melanoma in adults 
 
FDA 
 
03/2015 (accelerated approval): unresectable or metastatic melanoma and 
disease progression following ipilimumab and, if BRAF V600 mutation 
positive, a BRAF inhibitor  
 
Phase III results: 
Weber et al. Nivolumab versus chemotherapy in patients with advanced melanoma who 
progressed after anti-CTLA-4 treatment (CheckMate 037): a randomised, controlled, open-label, 
phase 3 trial. Lancet (2015) 16: 375–84. 
Background  
Nivolumab, a fully human IgG4 PD-1 immune checkpoint inhibitor antibody, can result in durable 
responses in patients with melanoma who have progressed after ipilimumab and BRAF inhibitors. We 
assessed the efficacy and safety of nivolumab compared with investigator’s choice of chemotherapy 
(ICC) as a second-line or later-line treatment in patients with advanced melanoma. 
 
 
Methods  
In this randomised, controlled, open-label, phase 3 trial, we recruited patients at 90 sites in 14 
countries. Eligible patients were 18 years or older, had unresectable or metastatic melanoma, and 
progressed after ipilimumab, or ipilimumab and a BRAF inhibitor if they were BRAF
V600
 mutation-
   
 
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positive. Participating investigators randomly assigned (with an interactive voice response system) 
patients 2:1 to receive an intravenous infusion of nivolumab 3 mg/kg every 2 weeks or ICC 
(dacarbazine 1000 mg/m2 every 3 weeks or paclitaxel 175 mg/m2 combined with carboplatin area 
under the curve 6 every 3 weeks) until progression or unacceptable toxic effects. We stratified 
randomisation by BRAF mutation status, tumour expression of PD-L1, and previous best overall 
response to ipilimumab. We used permuted blocks (block size of six) within each stratum. Primary 
endpoints were the proportion of patients who had an objective response and overall survival. 
Treatment was given open-label, but those doing tumour assessments were masked to treatment 
assignment. We assessed objective responses per-protocol after 120 patients had been treated with 
nivolumab and had a minimum follow-up of 24 weeks, and safety in all patients who had had at least 
one dose of treatment. The trial is closed and this is the first interim analysis, reporting the objective 
response primary endpoint. This study is registered with ClinicalTrials.gov, number NCT01721746. 
 
Results  
Between Dec 21, 2012, and Jan 10, 2014, we screened 631 patients, randomly allocating 272 patients 
to nivolumab and 133 to ICC. Confirmed objective responses were reported in 38 (31・7%, 95% CI 23
・5–40・8) of the first 120 patients in the nivolumab group versus five (10・6%, 3・5–23・1) of 47 
patients in the ICC group. Grade 3–4 adverse events related to nivolumab included increased lipase 
(three [1%] of 268 patients), increased alanine aminotransferase, anaemia, and fatigue (two [1%] 
each); for ICC, these included neutropenia (14 [14%] of 102), thrombocytopenia (six [6%]), and 
anaemia (five [5%]). We noted grade 3–4 drug-related serious adverse events in 12 (5%) nivolumab 
treated patients and nine (9%) patients in the ICC group. No treatment-related deaths occurred. 
 
Conclusion 
Nivolumab led to a greater proportion of patients achieving an objective response and fewer toxic   
effects than with alternative available chemotherapy regimens for patients with advanced melanoma 
that has progressed after ipilimumab or ipilimumab and a BRAF inhibitor. Nivolumab represents a new 
treatment option with clinically meaningful durable objective responses in a population of high unmet 
need. 
 
2.3 Pembrolizumab (Keytruda®, MK-3475) in advanced melanoma 
 
Drug Description 
 
a human programmed death receptor-1 (PD-1)-blocking antibody 
 
Incidence in 
Austria 
1,551 newly diagnosed per year (2011), 12.2/100,000/year 
Approval 
status for 
this 
indication 
EMA 
 
07/2015: as monotherapy is indicated for the treatment of advanced 
(unresectable or metastatic) melanoma in adults 
 
FDA 
 
09/2014: indicated for the treatment of patients with unresectable or 
metastatic melanoma and disease progression following ipilimumab and, if 
BRAF V600 mutation positive, a BRAF inhibitor 
 
Phase III results: 
Robert et al. Pembrolizumab versus ipilimumab in advanced melanoma. NEJM (2015) 372:2521-
32. 
Background  
   
 
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The immune checkpoint inhibitor ipilimumab is the standard-of-care treatment for patients with 
advanced melanoma. Pembrolizumab inhibits the programmed cell death 1 (PD-1) immune checkpoint 
and has antitumor activity in patients with advanced melanoma. 
 
Methods  
In this randomized, controlled, phase 3 study, we assigned 834 patients with advanced melanoma in a 
1:1:1 ratio to receive pembrolizumab (at a dose of 10 mg per kilogram of body weight) every 2 weeks 
or every 3 weeks or four doses of ipilimumab (at 3 mg per kilogram) every 3 weeks. Primary end 
points were progression-free and overall survival. 
 
Results  
The estimated 6-month progression-free-survival rates were 47.3% for pembrolizumab every 2 weeks, 
46.4% for pembrolizumab every 3 weeks, and 26.5% for ipilimumab (hazard ratio for disease 
progression, 0.58; P<0.001 for both pembrolizumab regimens versus ipilimumab; 95% confidence 
intervals [CIs], 0.46 to 0.72 and 0.47 to 0.72, respectively). Estimated 12-month survival rates were 
74.1%, 68.4%, and 58.2%, respectively (hazard ratio for death for pembrolizumab every 2 weeks, 
0.63; 95% CI, 0.47 to 0.83; P = 0.0005; hazard ratio for pembrolizumab every 3 weeks, 0.69; 95% CI, 
0.52 to 0.90; P = 0.0036). The response rate was improved with Pembrolizumab administered every 2 
weeks (33.7%) and every 3 weeks (32.9%), as compared with ipilimumab (11.9%) (P<0.001 for both 
comparisons). Responses were ongoing in 89.4%, 96.7%, and 87.9% of patients, respectively, after a 
median follow-up of 7.9 months. Efficacy was similar in the two pembrolizumab groups. Rates of 
treatment-related adverse events of grade 3 to 5 severity were lower in the pembrolizumab groups 
(13.3% and 10.1%) than in the ipilimumab group (19.9%). 
 
Conclusion 
The anti–PD-1 antibody pembrolizumab prolonged progression-free survival and overall survival and 
had less high-grade toxicity than did ipilimumab in patients with advanced melanoma. (Funded by 
Merck Sharp & Dohme; KEYNOTE-006 ClinicalTrials.gov number, NCT01866319.) 
 


HASH(0x558738cc3e10)

Ujeyl, M.

HASH(0x558738ef8838)

Nachtnebel, A

HASH(0x558738b63720)

Wild, C.

HASH(0x558738e5be80)

Winkler, R.

HASH(0x558738c6d980)

Zechmeister-Koss, I.

HASH(0x558738c72de0)

Gregor-Patera, N.

HASH(0x558738cc8430)

Naimer, Ch.

Piso, B.

HASH(0x558738c5cad8)

Khan, A.

Erdos, J.

RHEUMATOLOGIE
10,45%
€ 119.753.–
HÄMATOONKOLOGIE
19,53%
€ 223.755.–
NEUROLOGIE
25,58%
€ 293.114.–
DARMERKRANKUNGEN
HERZ/ KREISLAUF
ERKRANKUNGEN
1,02%
€ 11.700.–
SOZIALE 
INITIATIVEN
4,02%
€  46.004.–
HEPATITIS UND 
LEBERERKRANKUNGEN
HIV/ AIDS
1,93%
€ 22.150.–
6,84%
€ 78.365.–
PSYCHIATRIE UND 
SEELISCHE GESUNDHEIT
5,47%
€  62.627.–
SELTENE 
ERKRANKUNGEN
4,46%
€ 51.070.–
1,67%
€ 19.160.–
HÄMOPHILIE
7,47%
€ 85.600.–
DIABETES
5,28%
€ 60.530.–
Unterstützung österreichischer PatientInneninitiativen durch PHARMIG-Mitgliedsunternehmen 2014*
(Zusammenfassung nach Krankheitsfeldern und begünstigten PatientInnenorganisationen;  Im Flussdiagramm berücksichtigte Sponsorenbeträge: über €10.000.– ; Stand: Juli 2015; www.hta.lbg.ac.at / Grafik: mmp; www.multimediaproduktionen.at)
Unterstützung österreichischer PatientInneninitiativen durch PHARMIG-Mitgliedsunternehmen 2014: Zusammenfassung nach Krankheitsfeldern und begünstigten PatientInnenorganisationen 
( Stand: Juli 2015; www.hta.lbg.ac.at / Grafik: mmp; www.multimediaproduktionen.at)
LUNGENERKRANKUNGEN
4,57%
€ 52.336.–
*Sponsorengelder Gesamtbetrag  € 1.145.718.–
HÄMATOONKOLOGIE
€ 223.755.– / 19,53%
Roche: 66.600 (= 30% von 223.755)
Novartis: 44.140 (= 20%) 
Janssen: 33.500 (=15%)
Myelom und Lymphomhilfe Österreich
53.804 (= 24% von 223.755)
Multiples Myelom SHG
31.804 (= 14%) 
Europa Donna
40.222 (=18%)
RHEUMATOLOGIE
€ 119.753.– / 10,45%
Abbvie: 50.463 (= 42% von 119.753)
Pfizer: 27.000 (= 23%)
Roche: 18.000 (= 15%)
Österreichische Rheumaliga
45.323 (= 38% von 119.753)
Rheumalis
25.053 (= 21%)
Österr. Vereinigung Morbus Bechterew
25.027 (= 21%)
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€ 85.600.– / 7,47%
Bayer: 45.600 (=53% von 85.600)
Novo Nordisk: 21.000 (= 25%)
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Gesellschaft
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Bristol- Myers Squibb: 28.700
 (= 37% von 78.365)
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68.023 (= 87% von 78.365)
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SEELISCHE GESUNDHEIT
€ 62.627.– / 5,47%
Lundbeck: 38.929 (= 62% von 62.627)
Gilead: 15.000 (= 24%)
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DIALOG - Suchtgefährdete 
15.000 (=24% von 62.627)
HPE Österreich
11.000 (= 18%)
SELTENE 
ERKRANKUNGEN
€ 51.070.– / 4,46%
Sanofi: 29.570 (=58% von 51.070)
Novartis: 9.000 (=18%)
Actelion: 4.500 (=9%)
Pro Rare
13.800 (=27% von 51.070)
FHchol / 9.282 (=18%)
Verein Tuberöse Sklerose
9.000 (=18%)
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SOZIALE INITIATIVEN
€ 46.004.– / 4,02%
Pfizer: 16.500 (=36% von 46.004)
Lundbeck: 12.500 (=27%)
Novartis: 10.600 (=23%)
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16.000 (=35% von 46.004)
DARMERKRANKUNGEN
€ 19.160.– / 1,67%
Abbvie: 19.160 (=100% von 19.160)
Österr. Morbus Crohn-Colititis 
ulcerosa Vereinigung
19.160 (= 100% von 19.160)
NEUROLOGIE
€ 293.114.– / 25,58% 
Novartis: 164.900 (= 56% von 293.114) 
Lundbeck: 56.718 (= 19%) 
Abbvie: 29.296 (= 10%)
Österreichische MS Gesellschaft
(155.000 = 53% von 293.114)
Österr. + regionale MS Gesellschaft
(190.900 [155.000+35.900] 65%) 
HAUTERKRANKUNGEN
€ 8.585.– / 0,75%
Abbvie: 7.193 (=84% von 8.585)
Actelion: 1.392 (=16%)
Forum Psoriasis
5.975 (=70% von 8.585)
ORGANVERSAGEN UND 
TRANSPLANTATION
€ 8.020.– / 0,7%
Novartis: 4.100 (=51% von 8.020)
Biotest: 2.000 (=25%)
Österr. Verband der Herz- 
und Lungentransplantierten
3.500 (=44% von 8.020)
KNOCHEN
ERKRANKUNGEN
€ 1.549.– / 0,14%
Amgen: 1.000 (65% von € 1.549)
Österr. Osteoporose SHG Wien
1.000.– (=65%)
KLEINWUCHS
€ 1.400.– / 0,12%
Pfizer: 1.000 (=71% von 1.400)
Bundesverband kleinwüchsige 
Menschen und ihre Familien
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HERZ/ KREISLAUF
ERKRANKUNGEN
€ 11.700.– / 1,02%
Bayer: 6.200 (=53% von 11.700)
Boehringer Ingelheim: 
2.500 (=22%)
Roche: 2.000 (=17%)
Österreichischer Herzverband
7.500 (=64% von 11.700)
Sponsorengelder Gesamtbetrag  € 1.145.718.–
HIV/ AIDS
€ 22.150.– / 1,93%
MSD: 8.800 (=40% von 22.150)
Janssen: 7.000 (=32%)
Bristol- Myers Squibb: 3.100 (=14%)
Aids Hilfe
12.050 (=54% von 22.150)
PULSHIV
6.100 (=28%)
DIABETES
€ 60.530.– / 5,28%
Bayer: 19.150 (=32% von 60.530)
Roche:15.800 (=26%)
Novo Nordisk: 11.520 (=19%)
Österr. Diabetikervereinigung
35.979 (=59% von 60.530)
Österreichische Diabetesgesellschaft
15.800 (=26%)
LUNGENERKRANKUNGEN
€ 52.336.– / 4,57%
Actelion: 13.636 (=26% von 52.336)
Novartis: 15.700 (=30%)
Boehringer Ingelheim: 10.000 (19%)
Österreichische Lungenunion
15.200 (=29% von 52.336)
LOT Austria
12.500 (=24%)
€


HASH(0x558738c72918)

Blagojevic, S.

HASH(0x558738d66720)

Ludwig Boltzmann Institute for Health Technology Assessment

Not a member yet