Tyvyt Plus Chemo Improved Outcomes in NSCLC Subset

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The benefit derived from Tyvyt plus chemotherapy was present regardless of whether previously treated patients with EGFR-mutated, non-squamous non-small cell lung cancer also received Byvasda.

Combination therapy with the anti-PD-1 antibody Tyvyt (sintilimab) plus chemotherapy provided a progression-free survival benefit in patients with EGFR-mutated, non-squamous non-small cell lung cancer (NSCLC) who progressed on previous EGFR-tyrosine kinase inhibitor (TKI) therapy, according to a survival analysis of the ORIENT-31 study.

These results remained consistent regardless of whether patients also received anti-VEGF antibody therapy with Byvasda (bevacizumab injection), according to a press release from Innovent, the manufacturer of Tyvyt.

“ORIENT-31 is globally the first prospective, randomized, double-blind phase 3 study that demonstrated significant (progression-free survival) benefit of combination therapy of anti-PD-1 antibody and chemotherapy with or without (Byvasda) in patients with EGFR mutated non-squamous NSCLC that progressed on prior EGFR-TKI therapy, which was revolutionary in immunotherapy,” Dr. Shun Lu, principal investigator of the ORIENT-31 study and professor in the oncology department of Shanghai Chest Hospital, said in the release.

For this analysis, researchers focused on analyzing the median progression-free survival (the time during and after treatment when a patient with cancer lives with the disease without worsening) in patients assigned Tyvyt plus chemotherapy; those assigned Tyvyt, Byvasda and chemotherapy; and patients assigned chemotherapy alone. Overall survival (the time from treatment when a patient with cancer is still alive) was also reported in this study.

During follow-up, the median progression-free survival was 7.2 months in the Tyvyt, Byvasda and chemotherapy group; 5.5 months in the Tyvyt and chemotherapy group; and 4.3 months in the chemotherapy group, according to the published results.

Patients assigned Tyvyt and chemotherapy demonstrated a significant improvement in progression-free survival compared with the other groups. A significant benefit for progression-free survival was also sustained when patients assigned Tyvyt, Byvasda and chemotherapy compared with those assigned chemotherapy alone.

The Tyvyt, Byvasda and chemotherapy group also had a longer overall survival compared with those treated with chemotherapy alone (21.1 months versus 19.2 months). However, the survival difference between the groups was not statistically significant, meaning that the researchers cannot rule out the chance that the difference among the groups occurred randomly rather than due to the treatments.

Side effects from treatment was consistent with previous study findings, according to the release. Those considered severe or worse occurred in 56% of patients assigned Tyvyt, Byvasda and chemotherapy; 41% in those assigned Tyvyt and chemotherapy; and 49% in patients assigned chemotherapy alone.

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