Avastin and pemetrexed combination gives lung cancer patients significantly more time without their
disease progressing
New Roche study in non-small cell lung cancer confirms importance of maintenance treatment
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that AVAPERL, a phase III study evaluating the
combination of Avastin® (bevacizumab) and chemotherapy for patients with previously untreated, advanced nonsquamous
non-small cell lung cancer (NSCLC) met its primary endpoint, giving lung cancer patients significantly
more time without their disease progressing. The results will be presented for the first time today at the European
Multidisciplinary Cancer Congress in Stockholm.
In AVAPERL, previously untreated NSCLC patients were given four cycles of Avastin, pemetrexed and cisplatin.
Those patients whose disease was controlled (i.e. did not progress) continued treatment with Avastin and
pemetrexed and lived for a median of 10.2 months without their disease getting worse (progression-free survival;
PFS). In the control arm, those patients who continued Avastin alone demonstrated a median PFS of 6.6 months
(HR=0.50; p>0.001). No new safety events were observed and adverse events in AVAPERL were consistent with
those observed in previous Avastin and pemetrexed clinical trials.
“A period of more than 10 months without disease progression is unprecedented in this group of patients,
suggesting that Avastin plus pemetrexed could potentially represent a new Avastin-based approach for people with
the most common form of lung cancer" said Hal Barron M.D. Chief Medical Officer and Head, Global Product
Development.
Avastin is approved in Europe for the first-line treatment of advanced non-squamous NSCLC in combination with
platinum based chemotherapy followed by Avastin as a single agent until disease progression based on a
significant survival benefit. AVAPERL is the first phase III study to investigate the combination of Avastin and
pemetrexed as maintenance therapy. A recent study of pemetrexed as maintenance treatment (PARAMOUNT)
demonstrated a PFS of 6.9 months for pemetrexed alone vs. 5.6m for placebo (HR=0.59, p<0.001).
Full results will be presented today in the Lung Cancer - Early and Metastatic session in Stockholm (13.45, Hall
C5).
About the AVAPERL study
AVAPERL (MO22089) is a multicentre, randomised, open-label phase III study in 362 patients with previously
untreated advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) investigating whether the
combination of Avastin and pemetrexed chemotherapy as continuation maintenance therapy further improves the
clinical outcomes compared to Avastin alone, in patients who have already received first-line Avastin-cisplatinpemetrexed
induction treatment. The primary endpoint of the study is progression-free survival (PFS). Secondary
endpoints include overall survival, objective response rate, duration of response, quality of life and safety profile.
disease progressing
New Roche study in non-small cell lung cancer confirms importance of maintenance treatment
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that AVAPERL, a phase III study evaluating the
combination of Avastin® (bevacizumab) and chemotherapy for patients with previously untreated, advanced nonsquamous
non-small cell lung cancer (NSCLC) met its primary endpoint, giving lung cancer patients significantly
more time without their disease progressing. The results will be presented for the first time today at the European
Multidisciplinary Cancer Congress in Stockholm.
In AVAPERL, previously untreated NSCLC patients were given four cycles of Avastin, pemetrexed and cisplatin.
Those patients whose disease was controlled (i.e. did not progress) continued treatment with Avastin and
pemetrexed and lived for a median of 10.2 months without their disease getting worse (progression-free survival;
PFS). In the control arm, those patients who continued Avastin alone demonstrated a median PFS of 6.6 months
(HR=0.50; p>0.001). No new safety events were observed and adverse events in AVAPERL were consistent with
those observed in previous Avastin and pemetrexed clinical trials.
“A period of more than 10 months without disease progression is unprecedented in this group of patients,
suggesting that Avastin plus pemetrexed could potentially represent a new Avastin-based approach for people with
the most common form of lung cancer" said Hal Barron M.D. Chief Medical Officer and Head, Global Product
Development.
Avastin is approved in Europe for the first-line treatment of advanced non-squamous NSCLC in combination with
platinum based chemotherapy followed by Avastin as a single agent until disease progression based on a
significant survival benefit. AVAPERL is the first phase III study to investigate the combination of Avastin and
pemetrexed as maintenance therapy. A recent study of pemetrexed as maintenance treatment (PARAMOUNT)
demonstrated a PFS of 6.9 months for pemetrexed alone vs. 5.6m for placebo (HR=0.59, p<0.001).
Full results will be presented today in the Lung Cancer - Early and Metastatic session in Stockholm (13.45, Hall
C5).
About the AVAPERL study
AVAPERL (MO22089) is a multicentre, randomised, open-label phase III study in 362 patients with previously
untreated advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) investigating whether the
combination of Avastin and pemetrexed chemotherapy as continuation maintenance therapy further improves the
clinical outcomes compared to Avastin alone, in patients who have already received first-line Avastin-cisplatinpemetrexed
induction treatment. The primary endpoint of the study is progression-free survival (PFS). Secondary
endpoints include overall survival, objective response rate, duration of response, quality of life and safety profile.
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