GIST patients taking Novartis drug Glivec

GIST patients taking Novartis drug Glivec .

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Study in JAMA reports significant survival benefit in certain GIST patients taking Novartis drug Glivec® for three years after surgery

 

  • First large Phase III study to demonstrate significant survival benefits of extending treatment with Glivec for three years compared to one year following surgery
  • Important finding for treatment of KIT+ GIST patients who are at risk of recurrence following complete resection of primary tumor
  • Publication follows European Commission approval of new label based on these data

 

The Journal of the American Medical Association (JAMA) today published a Phase III study that showed significant survival benefits for patients meeting the study inclusion criteria who received three years of treatment with Glivec® (imatinib)[1] after surgery to remove KIT (CD117)-positive gastrointestinal stromal tumors (KIT+ GIST) compared to one year of treatment[1]. The study results were first presented at the 47th Annual Meeting of the American Society of Clinical Oncology (ASCO) plenary session in June 2011[2].

 

Gastrointestinal stromal tumors are a rare, life-threatening cancer of the gastrointestinal tract. The major cause of GIST is an abnormal form of the protein KIT which causes cells to grow uncontrollably and become cancerous[3]. Patients with GIST are at risk of recurrence following complete resection of primary GIST[4].

 

According to data published in JAMA from this international, multicenter, open-label Phase III clinical trial, at five years, 66% of patients taking Glivec for three years after surgery for KIT+ GIST remained free of recurrence (RFS) compared to 48% who had received Glivec for only one year after surgery (p<0.001; HR 0.46, 95% CI 0.32-0.65). In addition, at five years, 92% of patients taking Glivec for three years after surgery were alive (OS) compared to 82% who had received Glivec for only one year after surgery (p=0.02; HR 0.45, 95% CI 0.22-0.89). Four hundred patients entered the study. Median patient follow-up was 54 months[1].

 

Based on this data, in February 2012, the European Commission approved an update to the Glivec label to include three years of treatment after surgery for adults with KIT+ GIST.

 

“This study shows a significant recurrence-free survival benefit in adults with KIT+ GIST from adjuvant treatment with Glivec and provides important evidence to inform the clinical care of these patients after surgery,” said Heikki Joensuu, M.D., Ph.D., Professor, Oncology, University of Helsinki. “These data are likely to result in a new standard of care for these patients.”

 

About the SSG Phase III trial

This multicenter, prospective, randomized study for the evaluation of adjuvant treatment with Glivec of histologically confirmed KIT+ GIST was conducted by the Scandinavian Sarcoma Group (SSG) and the Sarcoma Group of the Arbeitsgemeinschaft Internistische Onkologie (AIO)[5]. The primary endpoint was to compare, within the first five years, recurrence-free survival in patients with a greater than 50% estimated risk of GIST disease recurrence, following diagnosis and treatment with adjuvant Glivec for either 12 or 36 months. The secondary endpoints included overall survival and treatment safety[2].

 

Inclusion criteria for risk of recurrence was defined as tumor diameter >5.0 cm and mitotic count >5/50 high power fields (HPFs); or tumor diameter >10.0 cm; or tumor of any size with a mitotic count >10/50 HPFs; or tumors ruptured into the peritoneal cavity.

 

Almost all patients experienced side effects while taking Glivec. Glivec was generally well tolerated. The proportion of patients who discontinued Glivec during the assigned treatment period for reasons other than GIST recurrence was 25.8% in the 36-month group and 13% in the 12-month group[2].

 

Novartis provided the study drug and supported the study financially. Additional funding was received from the Academy of Finland, Cancer Society of Finland, Sigrid Juselius Foundation and Helsinki University Research Funds.

 

About Glivec (imatinib)

Glivec® (imatinib) is approved in more than 110 countries for the treatment of all phases of Ph+ CML, for the treatment of adult patients with KIT (CD117)-positive gastrointestinal stromal tumors (GIST), which cannot be surgically removed and/or have metastasized and for the treatment of adult patients following complete surgical removal of KIT+ GIST.

Source: Novartis Release.