IN FIRST-LINE FOLLICULAR LYMPHOMA PATIENTS WHO RESPONDED TO R-CHEMO

RITUXAN MAINTENANCE THERAPY REDUCED THE RISK OF PROGRESSION, RELAPSE, OR DEATH BY 46% AND EXTENDED TIME IN REMISSION 1

*In a Kaplan-Meier PFS curve, when the patient population gets smaller, either due to availability for analysis or progression, a single event can result in a drastic drop in the curve. PFS assessment after 27 months is based on <10% of the patient population and the plot cannot be used to reliably predict PFS beyond this time point.

  • The risk of progression, relapse, or death nearly doubled (1.85x) for patients in the observation arm (P<0.0001)

The risk of progression, relapse, or death for the observation arm of the PRIMA trial was calculated using the formula 1/HR.

RITUXAN MAINTENANCE FOLLOWING A RESPONSE TO FIRST-LINE R-CHEMO SHOWED HIGHER RESPONSE RATES AT 2 YEARS VS OBSERVATION 2,5

RESPONSE RATES IN THE RANDOMIZED POPULATION BASED ON INVESTIGATOR ANALYSIS 2,5

Patients who did not respond to induction were not randomized to the maintenance or observation stage in PRIMA.

§N values do not include the patients (n=231) still undergoing RITUXAN maintenance or observation at the time of the interim analysis. 2

  • Two-year response rates were a prespecified secondary endpoint in the PRIMA trial 5

SELECT IMPORTANT SAFETY INFORMATION

SINGLE-AGENT RITUXAN AS MAINTENANCE FOR FOLLICULAR NHL AFTER FIRST-LINE RITUXAN-BASED CHEMOTHERAPY

  • Detailed safety data collection was limited to Grade ≥2 infections, Grade ≥3 adverse reactions, and serious adverse reactions
  • The most common Grade 3-4 adverse reactions occurring at a higher incidence (≥2%) in the RITUXAN arm than in the observation arm were infections (4% vs. 1%) and neutropenia (4% vs. <1%)
  • The most frequently reported adverse reaction was infections. In patients receiving RITUXAN as single-agent maintenance therapy following RITUXAN plus chemotherapy, infections were reported more frequently compared with the observation arm (37% vs. 22%)

R-CHEMO=RITUXAN plus chemotherapy; HR=hazard ratio; CI=confidence interval; PFS=progression-free survival; IRC=Independent Review Committee; PRIMA=Primary RItuximab and MAintenance; CR=complete response; CRu=complete response, unconfirmed; PR=partial response; ORR=overall response rate.

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