ע”פ הודעה שהפיקה חברת Merck (מרק גרמניה, לא MSD) מימצאים עדכניים ממחקר קליני שנערך עם ( Erbitux (cetuximab ואשר הוצגו בכנס ASCO המתקיים כעת, הראו שהטיפול בתכשיר בשילוב עם טיפול הקו הראשון הסטנדרטי בסרטן גרורתי של המעי הגס, השיג יעילות גבוהה ביותר.

התוצאות שהוצגו הם על בסיס נתונים ראשוניים ממחקר ה-ACROBAT שבה נבדקה יעילות הארביטוקס כטיפול משולב עם קו הטיפול הראשוני, ה-FOLOX-4 (הכולל את: Oxaliplatin, folinic acid,  5fluorouracil  ) .

נמצא שיעור תגובה כולל של 81% לטיפול, ומשך דחיית התקדמות מחלה של 12.3 חודשים, עם 52% של מטופלים המוגדרים כמשוחררים מהתקדמות המחלה בחודש ה-12 לטיפול. כמו כן 21% מהמטופלים עם גרורות שלא היו ברות ניתוח לפני הטיפול יכלו לעבור לאחר הטיפול ניתוח להסרת הגרורות.

הערת המערכת: יש לציין שהאינדיקציה הנוכחית הנמצאת כעת בתהליכי אישור והגשה  לסל הבריאות בישראל היא כטיפול קו שלישי בסרטן מעי גס.

להלן הודעת החברה המלאה, באנגלית:

New data from three clinical trials demonstrate that Erbitux® (cetuximab) in the first-line setting shows a consistently high response rate, leading to an increased potential for surgical intervention in patients whose metastases have previously been inoperable.13 These preliminary findings, released today at the 41st annual meeting of the American Society of Clinical Oncology (ASCO), reinforce the potential of Erbitux not only to delay time to disease progression, but also the ability to shrink metastases to allow surgical resection with curative intent.13

Five-year overall survival is less than 5 percent in patients with metastatic colorectal cancer (mCRC).4 However, for patients undergoing surgical resection of their metastases with curative intent, five-year overall survival approximates 50 percent.5 This approach has been limited by the tumor response rate achieved by conventional chemotherapy.5 To date, Erbitux has shown consistently high response rates in several treatment settings using different types of chemotherapy13,68 and its ability to improve long-term survival is being explored.

“Although only a small population of patients has been studied, results underline the huge potential of Erbitux in metastatic colorectal cancer,” said Professor Eric Van Cutsem, University Hospital Gasthuisberg, Leuven, Belgium. “For patients with unresectable metastases, it is unlikely we can offer a curative option. Any advance which brings us closer to this potential is urgently needed.”

Preliminary data from one of the three studies, an international Phase II study (ACROBAT),1 show that Erbitux in combination with the standard first-line treatment of oxaliplatin, folinic acid and 5-fluorouracil (FOLFOX-4 regimen) yielded an overall response rate of 81 percent and delayed time to disease progression to 12.3 months, with 52 percent of patients free from disease progression at 12 months.1 Nine out of 42 patients (21 percent) with previously unresectable metastases were able to undergo surgery of their metastases (seven liver, one lung and one suprarenal gland).1 Data from this study are further supported by the results from two additional  Phase I/II studies released at ASCO.2 ,3

“These results are extremely encouraging as Erbitux in combination with FOLFOX-4 is showing some of the highest response rates ever reported in the first-line setting,” said Dr Josep Tabernero, Vall dHebron University Hospital, Barcelona. “Further long-term data will be required, and we look forward to the results of the ongoing Phase III trials.” 

In the studies, Erbitux showed a favorable safety profile and few additional side effects compared to those associated with standard chemotherapy.

Based on the international, randomized Phase II BOND study,6 Erbitux was approved in December 2003 in Switzerland and in February 2004 by the US FDA for the treatment of mCRC in patients whose tumors were no longer responding to irinotecan-based therapy. In June 2004, Erbitux was also approved in the EU. Phase III studies are now underway to explore the long-term survival benefit of Erbitux in the treatment of mCRC.

About Erbitux

Erbitux® is a first-in-class and highly active IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR). As a monoclonal antibody, the mode of action of Erbitux is distinct from standard non-selective chemotherapy treatments in that it specifically targets and binds to the EGFR. This binding inhibits the activation of the receptor and the subsequent signal-transduction pathway, which results in reducing both the invasion of normal tissues by tumor cells and the spread of tumors to new sites. 

The most commonly reported side effect with Erbitux is an acne-like skin rash that seems to be correlated with a good response to therapy.6 In approximately five percent of patients, hypersensitivity reactions may occur during treatment with Erbitux; about half of these reactions are severe.6

Erbitux has already obtained market authorization in Switzerland, the US, Mexico, Argentina, Chile, Iceland, Norway, the European Union, Peru, Australia, Croatia and Singapore for the use in combination with irinotecan in patients with EGFR-expressing metastatic colorectal cancer who have failed prior irinotecan therapy. In the US, Argentina, Chile, Mexico, Peru, Singapore and Australia, Erbitux is also approved for single agent usage.

References

1.       Diaz Rubio E et al. Presented at ASCO, Orlando, Florida, 2005: abstr 3535.

2.       Folprecht G et al. Proceedings ASCO, Orlando, Florida, 2005: abstr 3640.

3.       Seufferlein T et al. Proceedings ASCO, Orlando, Florida, 2005: abstr 3644.

4.       Mineo TC et al. J Am Coll Surg 2003 ; 197 :386-391

5.       Giacchetti S et al. Ann Oncol 1999; 10 (6): 663-9.

6.       Cunningham D et al. N Engl J Med 2004; 22; 351(4): 337-45.

7.       Saltz L et al. Proc Am Soc Clin Oncol 2001; Vol 20: abstr 7.

8.       Saltz L et al. J Clin Oncol 2004; 22 (7): 1-8.