CLINICAL TRIALS
Trial starts signal industry’s best bets
Citeline directors analyse clinical trials initiated in six key therapy areas over the past year,
outlining industry trends that may point to the way ahead
Figure 1: Oncology trials initiated in the past 12 months by disease
100
By Susan Danheiser, Citeline’s oncology director
In the oncology therapeutic area, a total of 550 industry-sponsored
Phase III
Phase II to Phase III trials were initiated between September 1st, 2007
and August 31st, 2008. Breast cancer was the leading tumour type
80
overall, comprising 16% of the total. Non-small cell lung cancer (NSCLC)
Phase II/III
trials were a close second, accounting for 11% of all trial starts, with
prostate cancer, colorectal cancer and non-Hodgkin’s lymphoma (NHL)
rounding out the top five. Breast cancer, NSCLC and prostate cancer
ts
60
Phase II
comprised the highest proportion of Phase III starts, at about 23% of
total late-stage trials for each. For colorectal cancer and NHL, the
proportion of Phase II to Phase III trial starts was higher (Phase III trials
T
rial star
represented only about 8% of the total for each). Further analysis can
40
determine if this reflects a larger number of drugs entering Phase II in
colorectal cancer and NHL, or a higher failure rate at the Phase II level in
these tumour types.
Outside the top five tumour types for overall late-stage trial starts,
notably higher proportions of Phase III vs Phase II starts were observed
20
for chronic myelogenous leukaemia, gastrointestinal stromal tumour
(GIST) and supportive care indications covered by TrialTrove. Phase III
studies accounted for 71%, 50% and 46%, respectively, of late-stage trial
starts in those indications. There were no industry sponsored Phase III
0
trials (single-indication) initiated in the past year for several tumour
er
e
east
eas
ome
types including head and neck cancer, mesothelioma, myelodysplastic
Br ostate
ectal Liv
Renal
coma
der oid
e car GIST yr
Pr
Gastric
Ovarian
y
eloma
tiv
Blad
Th syndromes, chronic lymphocytic leukaemia and acute lymphocytic
Color
ymphoma
Pancr
s l
Head/neck
Melanoma small cell ed cancer
leukaemia. However, the latter three cancers may be included in the few
non-small cell
glioblastoma
Suppor Lung,
Mesothelioma
Phase III trials involving multiple hematologic diseases.
Lung,
CNS,
Multiple m
elogenous leukaemia
Soft tissue sar Unspecif_i
Multiple solid tumours
y
elodysplastic syndr
y
elogenous leukaemia
ymphocytic leukaemiaymphocytic leukaemia
For hematologic cancers, the greatest number of late-stage trials were
Non-Hodgkin’ My
Multiple hematologic diseases
onic m
onic l
Acute m
Acute l initiated in NHL, multiple myeloma, myelodysplastic syndromes and
Chr
Chr
trials involving more than one hematologic cancer type.
Source: TrialTrove; accessed September 22nd, 2008
Figure 2: Oncology trials initiated in the past 12 months by company (top 20; Phase II-III)
35
According to TrialTrove, industry initiated 550 late-stage oncology
Phase III
clinical trials (Phases II–III) in the past 12 months (September 1st, 2007
30
to September 1st, 2008). Not surprisingly, the vast majority (80%) of
these were Phase II trials. Nearly 60% of late-stage trials were sponsored
25
Phase II/III
by 20 companies, with Pfizer leading the pack. Indeed, Pfizer’s latest
pipeline update highlighted the company’s commitment to advancing
clinical development in “high-potential disease areas” including
ts
20 oncology. Following closely behind Pfizer for late-stage trial starts were
Phase II
Bristol-Myers Squibb, Genentech, AstraZeneca, Roche and Novartis.
Notable on this list are non-“big pharma” companies: Celgene, Abraxis
T
rial star
15
and Taiho.
Pfizer, Novartis, GlaxoSmithKline and Genentech/Roche initiated the
10
largest number of Phase III oncology trials in the past year, followed
closely by AstraZeneca and Sanofi-Aventis. Pfizer, Genentech and Roche
led in Phase II starts. GSK, Sanofi-Aventis and Merck KGaA/Merck Serono
5
had the highest ratio of Phase III to Phase II trial starts.
The majority of late-stage trials initiated by Pfizer were in renal cell
carcinoma (not breast cancer as might be suspected), followed by
0
NSCLC, prostate cancer and small cell lung cancer. Breast cancer was
tis
y
Lill ono
Pf_izer Roche var v
entis Eisai the fifth most frequent indication for Pfizer-sponsored trial starts.
ers Squibb
No
Celgene ck & Co
Amgen Roche
Genentech
ck Ser However, breast cancer was the lead indication in trials initiated by
AstraZeneca Mer
Sanof_i-A
GlaxoSmithKline
Bristol-Myers Squibb, Genentech, AstraZeneca, Roche and Novartis.
ImClone Systems
Schering-Plough
Genentech;
Bristol-My y
er Schering Pharma Abraxis BioScience
Ba
T
aiho Pharmaceutical
ck KGaA/Mer
Mer
Source: TrialTrove; accessed September 22nd, 2008
80
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