Findings From the Full Analysis (Measurable and Non-Measurable Lesions)

Findings From the Full Analysis (Measurable and Non-Measurable Lesions)

Blog Article

In the CNS-BICR full analysis set, the ORR was 73% (95% CI, 64-81) in the osimertinib plus chemotherapy group and 69% (95% CI, 59-78) in the osimertinib monotherapy group. Of note, 59% (n = 70) of patients assigned osimertinib plus chemotherapy achieved a CR to therapy compared with 43% (n = 45) of those assigned monotherapy.

The median CNS DOR in this analysis was not reached (NR) in the osimertinib plus chemotherapy group (95% CI, 23.8-not calculable [NC]) compared with 26.2 months (95% CI, 19.4-NC) in the osimertinib only group.

Ultimately, the addition of chemotherapy Osicent 80 mg (Osimertinib) reduced the risk of CNS-related disease progression or death by 42% (HR, 0.58; 95% CI, 0.33-1.01) in this population.2 At 12 months, the rates of PFS were 87% vs 83% between the combination and monotherapy groups, respectively. At 24 months, the rates were 74% vs 54%.

Results Among Those With Measurable Lesions

For the CNS evaluable for response set, the CNS ORR was 88% (95% CI, 73%-96%) among patients assigned osimertinib plus chemotherapy and 87% (95% CI, 72%-96%) among patients receiving osimertinib monotherapy. Complete responses were achieved by 48% (n = 19) vs 16% (n = 40) of patients, respectively.

The median CNS DOR in this set was not reached in the osimertinib plus chemotherapy group (95% CI, 21.6-NC) and 20.9 months in the osimertinib alone group (95% CI, 12.6-NC).

In this population, the addition of chemotherapy reduced the risk of progression or death by 60% (HR, 0.40; 95% CI, 0.19-0.84). At 12 months, the PFS rates were 89% vs 73%. At 24 months, the rates were 65% vs 37%.

Safety Analysis

According to Planchard, the safety profiles were consistent with what investigators had expected.

Of note, more grade 3 or worse adverse events were reported in the dual therapy arm. Hematological toxicities were the most reported. Regarding interstitial lung disease, 9 patients (3%) and 10 patients (4%) reported this event in the combination and monotherapy groups. Toxicities were most frequent and severe during the induction period and were reported to gradually recede over time.

“Osimertinib has proven ability to cross the blood-brain barrier and improve outcomes for patients with lung cancer and CNS metastases, who often face a poorer prognosis than patients whose disease has not spread to the brain,” said in a press release from AstraZeneca, the manufacturer of osimertinib. “In FLAURA2, the addition of chemotherapy to osimertinib led to a complete response and the disappearance of these tumors in the brain in more than half of these patients.

 

Phone: +8801933042721
Email: iebpharma108@gmail.com
Sector 3, Road 8, Uttara-1230 Dhaka, Bangladesh
website: https://iebpharma.com