- Results from a randomized Phase IIb trial reported at 2009 ASCO Annual
Meeting -
MISSISSAUGA, ON, June 1 /CNW/ - YM BioSciences Inc. (NYSE Amex:YMI,
TSX:YM, AIM:YMBA), a life sciences product development company that identifies
and advances a diverse portfolio of promising cancer-related products at
various stages of development, today reported that results from a randomized
trial of nimotuzumab (aka BIOMAb/TheraCIM/h-R3) in patients with inoperable,
locoregionally advanced Stage III/IVa head and neck cancer conducted by Reddy
BK et al (Kidwai Memorial Institute of Oncology, Bangalore, India), were
presented in a poster at the 2009 ASCO Annual Meeting. The trial demonstrates
that the efficacy of nimotuzumab compares favorably to results reported for
cetuximab, an EGFR-targeting antibody marketed as Erbitux(R), but that this
efficacy was not accompanied by the severe toxicities reported in patients
treated with cetuximab. The authors further conclude that this trial is the
first randomized study in head and neck cancer to their knowledge that
challenges the adopted tenet that the efficacy of EGFR inhibitors is linked to
the toxicity of the class.
"These data are further evidence of the unsupported extrapolation to the
class of the toxicity/benefit correlation in the marketed EGFR drugs. The
trial data demonstrate that patients have the prospect of equivalent clinical
benefit from nimotuzumab as from the rest of the class without the physical,
emotional and financial costs that result from the numerous and severe
toxicities of Erbitux(R) which are a consequence of the demonstrable inability
of that drug to discriminate between healthy cells and tumor cells," said
David Allan, Chairman and CEO of YM BioSciences. "We expect that, as the
numerous randomized trials currently ongoing worldwide with nimotuzumab
report, the evidence for this claim will become increasingly robust."
Reddy BK et al. conducted a randomized Phase IIb, four-arm, open-label
study designed to assess the safety and efficacy of nimotuzumab in combination
with radiation therapy (RT) or chemoradiation therapy (CRT) in patients with
inoperable (Stage III or IVa) squamous cell carcinoma of the head and neck
(SCCHN). Stage III-IV SCCHN patients are reported to account for 50-60% of
head and neck cancer patients. A total of 92 patients were enrolled of which
76 were considered evaluable. The addition of nimotuzumab to both the
radiation and chemoradiation regimens improved the overall response rate,
survival rate at 30 months, median progression-free survival and median
overall survival. A combined group analysis of the nimotuzumab arms vs. the
non-nimotuzumab arms demonstrated a significant difference in overall survival
(p(equal sign)0.0018) favoring nimotuzumab. The addition of nimotuzumab did not add to
the severe toxicities of either regimen, with no Grade 3-4 skin toxicities
observed. The results of the study are presented in the table below.
Summary of Efficacy Parameters - Reddy BK et al study:
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PARAMETER GROUP A GROUP B
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RT+ CRT+
RT nimotuzumab CRT nimotuzumab
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Overall Response Rate
(ORR (equal sign) CR + PR) (%) 37 76 70 100
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Survival Rates at 30 Months (%) 21.70 39.10 21.70 69.50(x)
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Median Progression Free
Survival (Months) 6.90 20.71 21.30 NR
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Median Overall Survival at
30 months (Months) 15.07 NR 25 NR
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(x) Statistically significant; NR (equal sign) Not reached at 30 months
The response rates observed by the authors compare favorably with
previous studies of cetuximab in combination with RT alone or CRT. Bonner JA
et al (N. Engl J Med.
