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IMS COM PANY PRO FILES TAKEDA
sponse of 18.1 weeks. Sta bi li za tion of dis ease was ob served in 29% of pa tients (n=43). Median
progression-free survival time was 13.6 weeks.
Lifecycle Man age ment: In June 2007 Amgen ini ti ated a phase III trial to as sess panitumumab in com -
bi na tion with che mo ther apy ver sus che mo ther apy alone as first-line ther apy for met a static and/or re cur -
rent squamous cell car ci noma of the head and neck (SCCHN). The pri mary out come mea sure of the trial,
which is be ing con ducted in the USA, Aus tra lia, Can ada and Eu rope and in volves 650 pa tients, is over all
sur vival. Panitumumab is also be ing eval u ated as a monotherapy in the sec ond-line treat ment of SCCHN.
Phase III tri als are also on go ing as a first- and sec ond-line treatment for colorectal cancer.
In 2005, Amgen and Abgenix ini ti ated a phase III trial of panitumumab in com bi na tion with Avastin
(bevacizumab) in the first-line treat ment of met a static colorectal can cer. The clin i cal trial called the
PACCE (Panitumumab Ad vanced Colorectal Can cer Eval u a tion) study has as end points pro gres sion-free
sur vival, over all sur vival and re sponse rate. In March 2007, Amgen dis con tin ued the trial due to a sta tis ti -
cally sig nif i cant ben e fit on sur vival fa vor ing the con trol arm. Amgen hoped PACCE would “leap frog”
Vectibix into the front-line set ting, de spite not being designed as a registration trial.
Com pe ti tion: In the 12-month pe riod to the end of Sep tem ber 2008, Vectibix was the num ber 14 lead -
ing prod uct in the ‘to tal other neoplastics’ ther a peu tic class, with a 0.6% mar ket share, down 21% in
fixed rate dol lar terms. Roche and its ma jor ity-owned sub sid iary Genentech dom i nate this class with its
MabThera (rituximab) in first place with 17.8% share (up 14%) fol lowed by Avastin (bevacizumab)
with 15.6%, up 38% and Herceptin (trastuzumab) in third place with 15.4% share, up 12% over the
pre vi ous 12-month pe riod. Erbitux took sixth place in the same pe riod with 5.5% share with 15% growth
over the previous year.
ImClone Sys tems (USA) and BM-S (USA) have a com pet i tor prod uct Erbitux (cetuximab) on the mar -
ket, launched in the USA in 2004 and now launched in sev eral Eu ro pean and other mar kets. Other com -
pet i tors are Genentech’s (USA)/Roche’s (Swit zer land) Avastin and Tarceva (erlotinib). Avastin has been
on the Jap a nese mar ket for ad vanced/re cur rent colorectal can cer, in com bi na tion with 5-FU che mo ther -
apy since June 2007. Avastin has also been filed in Ja pan for use in com bi na tion with Roche/Chugai’s
Xeloda (capecitabine) and Yakult Honsha’s chemotherapeutic Elplat (oxaliplatin), li censed from
Debiopharm) while Xeloda was filed the same month for colorectal can cer; Elplat is al ready in di cated for
colorectal can cer in com bi na tion with 5-FU and levofolinate.
Re sults of a 755-pa tient study (CAIRO II) pre sented in 2008 showed that the ad di tion of Erbitux to a
treat ment reg i men of FOLFOX and Avastin was as so ci ated with a lower pro gres sion free sur vival of 9.8
months com pared with 10.7 months in the con trol arm al though over all sur vival was sim i lar at 20.4
months ver sus 20.3 months with Erbitux. These re sults mir ror those that led to the dis con tinu a tion of the
Vectibix trial in early 2007 and ac cord ing to an a lysts the gap is clos ing be tween Erbitux and Vectibix with
the emer gence of the K-RAS as pect which could cre ate a sig nif i cant win dow of op por tu nity for Amgen.
Amgen is run ning the first phase III clin i cal tri als in colorectal can cer that pro spec tively de fines pa tient
KRAS status, gaining a potential edge over Erbitux.
The an a lyst said how ever that al though Amgen has at tempted to limit the la bel in the USA to the KRAS
wild type only, the FDA has show re sis tance at the ret ro spec tive anal y sis and may re quire an other trial
(which could take sev eral years). In De cem ber 2008, the FDA on col ogy ad vi sory com mit tee (ODAC) met
to dis cuss the use of KRAS mu ta tion sta tus as pre dic tive/prog nos tic biomarker to eval u ate pa tients more
likely to re spond to Vectibix and Erbitux. Eu ro pean la bel ing for the EGFR in hib i tors al ready lim its use to
pa tients with the KRAS wild-type gene. In No vem ber 2008, the US Na tional Com pre hen sive Can cer Net -
work (NCCN) rec om mended use of the EGFR in hib i tors (Vectibix and Erbitux) only for pa tients with wild
KRAS tumors in metastatic colorectal cancer.
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