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Amgen Highlights Phase 2 Results Of Vectibix® (panitumumab) Versus bevacizumab In Combination With FOLFOX In Patients With Wild-Type RAS (KRAS And NRAS) Metastatic Colorectal Cancer
The data presented at
In this exploratory analysis, patients who received panitumumab plus FOLFOX and were then treated with a VEGF inhibitor-based treatment (including bevacizumab) had a median OS improvement of 41.3 months. By comparison, patients who received bevacizumab plus FOLFOX and were then treated with an anti-EGFR inhibitor-based treatment (including panitumumab/cetuximab), had a median OS improvement of 29.0 months. For both arms, outcomes were similar to those observed in the overall treated population with wild-type RAS mCRC.
"The initial PEAK data reinforce the potential importance of panitumumab for select patients, but we wanted to evaluate whether this benefit was dependent on administration with FOLFOX and if other subsequent treatments might impact survival outcomes," said
"The PEAK study not only shows the survival benefit of panitumumab in patients who have metastatic colorectal cancer with wild-type KRAS tumors, but also gets us another step closer to understanding how unique genetic markers may change the way we treat cancers," said
Colorectal cancer is the third most common cancer in the U.S., and is the second leading cause of cancer deaths.1,2 Approximately 1.2 million cases of colorectal cancer are expected to occur globally.3
About Vectibix® (panitumumab)
Vectibix is the first fully human anti-EGFR antibody approved by the
Important U.S. Product Information
Vectibix is indicated for the treatment of patients with wild-type KRAS (exon 2 in codons 12 or 13) mCRC as determined by an
- As first-line therapy in combination with FOLFOX
- As monotherapy following disease progression after prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy
Vectibix is not indicated for the treatment of patients with KRAS-mutant mCRC or for whom KRAS mutation status is unknown.
WARNING: DERMATOLOGIC TOXICITY
Dermatologic Toxicity: Dermatologic toxicities occurred in 90 percent of patients and were severe (NCI-CTC grade 3 or higher) in 15 percent of patients receiving Vectibix monotherapy. [See Dosage and Administration (2.1), Warnings and Precautions (5.1), and Adverse Reactions (6.1)].
Determination of KRAS mutational status in colorectal tumors using an
Progressively decreasing serum magnesium levels leading to severe (Grade 3-4) hypomagnesemia occurred in up to 7% of patients across clinical trials. Monitor patients for hypomagnesemia and hypocalcemia prior to initiating Vectibix treatment, periodically during Vectibix treatment, and for up to 8 weeks after the completion of treatment.
In a clinical trial, 4% of patients experienced infusion reactions and 1% of patients experienced severe infusion reactions (NCI-CTC grade 3-4).
Severe diarrhea and dehydration, leading to acute renal failure and other complications, have been observed in patients treated with Vectibix in combination with chemotherapy.
Fatal and non-fatal cases of interstitial lung disease (ILD) (1%) and pulmonary fibrosis have been observed in patients treated with Vectibix. Pulmonary fibrosis occurred in less than 1% (2/1467) of patients enrolled in clinical studies of Vectibix. In the event of acute onset or worsening of pulmonary symptoms, interrupt Vectibix therapy. Discontinue Vectibix therapy if ILD is confirmed.
The most common adverse reactions of Vectibix are skin rash with variable presentations, paronychia, fatigue, nausea and diarrhea. The most frequently reported serious, adverse reactions of Vectibix are general physical health deterioration, and intestinal obstruction.
The most commonly reported adverse reactions (> 20%) in patients with wild-type KRAS mCRC receiving Vectibix (6 mg/kg every 2 weeks) and FOLFOX therapy (N = 322) in Study 3 were diarrhea, stomatitis, mucosal inflammation, asthenia, paronychia, anorexia, hypomagnesemia, hypokalemia, rash, acneiform dermatitis, pruritus, and dry skin. Serious adverse reactions (≥ 2% difference between treatment arms) in Vectibix-treated patients with wild-type KRAS mCRC were diarrhea and dehydration.
To see the full Vectibix Safety Information, visit www.vectibix.com.
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1 Colorectal Cancer Facts and Figures.
2 Colorectal Cancer Prevention (PDQ®).
3 Jemal. Global Cancer Statistics. CA Cancer J Clin. 2011;61:69-90.