European Medicines Agency Offers Positive Opinion Bevacizumab Based Treatment Beyond First Progression in People With Advanced Colorectal

Colorectal cancer is one of the most common cancers in the world, with over 1.2 million new cases diagnosed each year. The disease remains one of the biggest cancer killers in the world responsible for over 600,000 deaths globally each year [1].

Recent studies show that continued use of bevacizumab (Avastin®; Roche/Genentech) -based therapy beyond first progression in metastatic colorectal cancer patients leads to survival benefits. These results are from data from the ML18147 study, a randomised, open-label phase III multicentre, multinational trial evaluating the efficacy and safety profile of bevacizumab plus standard second-line chemotherapy in 820 patients with mCRC whose disease had progressed following bevacizumab plus standard first-line chemotherapy (irinotecan or oxaliplatin-based). Patients were randomised at progression to one of two treatment arms:

  • Arm A: Chemotherapy [2] plus bevacizumab (equivalent of 2.5 mg/kg i.v. per week)
  • Arm B: Chemotherapy [2] alone

The primary endpoint of the study was overall survival measured from the time patients were randomised to the second-line treatment. The secondary efficacy endpoints of the study included PFS, overall response rate and safety profile.

Positive Opinion

Based on these the Committee for Medicinal Products for Human Use (CHMP) granted a positive opinion for the addition of data from the ML18147 study to the current European label of bevacizumab. This will allow people diagnosed with metastatic colorectal cancer who receive bevacizumab plus chemotherapy as a first line treatment to continue to receive bevacizumab plus chemotherapy after their cancer worsens as a second line treatment.

Application

The ML18147 study, the basis of the application, demonstrated that people with metastatic colorectal cancer who were initially treated with bevacizumab, lived longer when they continued on bevacizumab-based therapy after their disease had progressed for the first time, than those who received only chemotherapy after disease progression. The results from ML18147 were first presented at ASCO 2012 (abstract #CRA3503 [3]). Continuing bevacizumab-based therapy had minimal additional impact on frequency of adverse events and the adverse event profile for bevacizumab in this study was consistent with previous studies in colorectal cancer.

"People with metastatic colorectal cancer who continued Avastin treatment with a new chemotherapy regimen after their cancer worsened lived longer than patients who changed to a new chemotherapy only,” said Hal Barron M.D., Roche’s Chief Medical Officer and Head of Global Product Development. “This positive CHMP opinion is an important step towards potentially changing the approach to treatment of metastatic colorectal cancer and providing a new option for patients.”

With the initial approval in the USA for advanced colorectal cancer in 2004, bevacizumab became the first antiangiogenic therapy made widely available for the treatment of patients with an advanced cancer. Today, bevacizumab is the only biological therapy proven to increase overall survival when used first-line, beyond first progression, and in second-line treatment of metastatic colorectal cancer.

References:

[1] WHO, IARC GLOBOCAN, Cancer Incidence and Mortality Worldwide in 2008

[2] Depending on the first-line chemotherapy backbone (fluoropyrimidine / irinotecan-based or fluoropyrimidine / oxaliplatin-based) the chemotherapy backbone was switched in the second-line setting.

[3] Arnold D, Andre T, Bennouna J, Sastre J, Osterlund PJ, Greil R, Van Cutsem E, et al.  Bevacizumab (BEV) plus chemotherapy (CT) continued beyond first progression in patients with metastatic colorectal cancer (mCRC) previously treated with BEV plus CT: Results of a randomized phase III intergroup study (TML study). J Clin Oncol 30, 2012 (suppl; abstr CRA3503)

For more information:

- MedlinePlus Duginfo: Bevacizumab

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Tags: /, ASCO, Advanced, Agency, Avastin, Bevacizumab, CRA3503, Colorectal, European, Genentech, More…Medicines, Opinion, People, Positive, Progression, Roche, Treatment, fluoropyrimidine, irinotecan-based, metastatic, or, oxaliplatin-based

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