Celebrating Today’s Accomplishments and Tomorrow’s Possibilities

Currently, lung cancer is the leading cause of cancer deaths in the United States and pancreatic cancer is the fourth-leading cause of cancer deaths.¹ Tarceva has demonstrated a survival advantage and generally manageable common adverse events in both of these complex disease states.

Since its introduction to the US market 5 years ago, Tarceva has achieved multiple “firsts,” which has led to its widespread and continued use.

Tarceva is the FIRST and only oral EGFR TKI in the second-line setting to demonstrate a significant improvement in survival in a broad range of NSCLC patients across all histologies.2 In unselected patients in a phase III NSCLC trial vs placebo:
- Tarceva lengthened median survival (6.7 months vs 4.7 months, respectively; HR=0.73; 95% CI=0.61-0.86).²
- Tarceva prolonged overall survival by 37% (HR=0.73; P<0.001).²
Tarceva is the FIRST and only approved oral EGFR TKI in the second-line setting to demonstrate a significant improvement in disease control rate (CR+PR+SD) in a broad range of NSCLC patients across all histologies.³
- In unselected patients in a phase III NSCLC trial vs placebo, Tarceva improved the disease control rate (44.0% vs 27.5%, respectively).³
Tarceva is the FIRST FDA-approved therapy in more than a decade shown to improve median overall and one-year survival in advanced pancreatic cancer patients when given in addition to gemcitabine.²
- In the pivotal phase III trial evaluating Tarceva plus gemcitabine vs gemcitabine alone, the Tarceva combination significantly improved overall survival outcomes by 23% vs gemcitabine alone (HR=0.81; 95% CI=0.68-0.97; P=0.028).²
  - Median survival improved by approximately 2 weeks (6.4 months vs 6.0 months).²
  - One-year survival was 23.8% with Tarceva plus gemcitabine vs 19.4% with gemcitabine alone.²
Tarceva is the FIRST NSCLC treatment to demonstrate improved median overall survival in several key subsets based on a retrospective, exploratory subset analysis.³
- Tarceva more than doubled median survival vs placebo in patients with PS 0/1, squamous-cell histology (10.0 months vs 4.2 months, respectively; HR=0.46; 95% CI=0.26-0.81).³
- Tarceva tripled median survival vs placebo in female patients with adenocarcinoma (11.75 months vs 3.91 months, respectively; HR=0.41; 95% CI=0.23-0.72).³
- Tarceva tripled median survival vs placebo in never smokers (13.37 months vs 4.32 months, respectively; HR=0.27; 95% CI=0.15-0.51).³
- The data presented cannot be extrapolated to patients outside the identified subsets. The safety profiles of the patients in the identified subsets are unknown.
Genentech and OSI Pharmaceuticals are committed to conducting ongoing research that will lead to more FIRSTS in changing the way NSCLC is treated.

Indications and usage

Second-line Advanced NSCLC

Tarceva monotherapy is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen.

Results from two multicenter, placebo-controlled, randomized, Phase III trials conducted in first-line patients with locally advanced or metastatic NSCLC showed no clinical benefit with the concurrent administration of Tarceva with platinum-based chemotherapy, and its use is not recommended in that setting.

First-line Advanced Pancreatic Cancer

Tarceva in combination with gemcitabine is indicated for first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

Important Safety Information

There have been infrequent reports of serious Interstitial Lung Disease (ILD)-like events, including fatalities, in patients receiving Tarceva for treatment of NSCLC, pancreatic cancer or other advanced solid tumors. In the event of an acute onset of new or progressive, unexplained pulmonary symptoms such as dyspnea, cough and fever, Tarceva therapy should be interrupted pending diagnostic evaluation. If ILD is diagnosed, Tarceva should be discontinued and appropriate treatment instituted as needed.

Cases of hepatic failure, hepatorenal syndrome, acute renal failure (all including fatalities), and renal insufficiency have been reported during use of Tarceva. Treatment with Tarceva should be used with extra caution in patients with total bilirubin > 3 x ULN. Tarceva dosing should be interrupted or discontinued if changes in liver function are severe. Patients should be closely monitored during therapy with Tarceva.

Gastrointestinal perforation (including fatalities) has been reported in patients receiving Tarceva. Permanently discontinue Tarceva in patients who develop gastrointestinal perforation.

Bullous, blistering and exfoliative skin conditions have been reported including cases suggestive of Stevens-Johnson syndrome/toxic epidermal necrolysis, which in some cases were fatal. Interrupt or discontinue Tarceva treatment if the patient develops severe bullous, blistering or exfoliating conditions.

In the pancreatic cancer trial, other serious adverse reactions associated with Tarceva plus gemcitabine and which may have included fatalities, were myocardial infarction/ischemia, cerebrovascular accident and microangiopathic hemolytic anemia with thrombocytopenia.

Corneal perforation and ulceration have been reported during use of Tarceva. Interrupt or discontinue Tarceva therapy if patients present with acute/worsening ocular disorders such as eye pain.

When receiving Tarceva therapy, women should be advised against becoming pregnant or breastfeeding. Tarceva is pregnancy category D.

The most common adverse reactions in patients with NSCLC receiving Tarceva monotherapy 150 mg were mild to moderate rash and diarrhea. Severe rash and diarrhea (9% & 6% NCI-CTC Grades 3-4, respectively) were reported. Rash and diarrhea each resulted in dose reductions (6% and 1%, respectively) and discontinuation in 1% of Tarceva-treated patients during the single-agent Phase III trial.

The most common adverse reactions in patients with pancreatic cancer receiving Tarceva 100 mg plus gemcitabine were fatigue, rash, nausea, anorexia and diarrhea. Severe rash and diarrhea (5% and 5% NCI-CTC Grades 3-4, respectively) were reported. Rash and diarrhea each resulted in dose reductions in 2% of patients, and discontinuation in up to 1% of patients receiving Tarceva plus gemcitabine.

Please see the Tarceva full prescribing information for complete safety information.

References:

1. American Cancer Society. Cancer Facts & Figures 2009. Atlanta, GA: American Cancer Society; 2009.
2. Tarceva [package insert]. Melville, NY: OSI Pharmaceuticals Inc; 2009.
3. Data on file, OSI Pharmaceuticals Inc.