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Association details:
| Biomarker: | EGFR mutation |
|---|---|
| Cancer: | Lung Non-Squamous Non-Small Cell Cancer |
| Drug: | Tyvyt (sintilimab) (PD1 inhibitor) + Byvasda (bevacizumab biosimilar) (VEGF-A inhibitor) |
| Direction: | Sensitive |
Evidence:
Title:
The China NMPA Approves TYVYT® (sintilimab injection) in Combination with Bevacizumab and Chemotherapy in Patients with EGFR-mutated Non-squamous NSCLC who Progressed after EGFR-TKI Therapy
Published date:
05/09/2023
Excerpt:
Innovent Biologics...and Eli Lilly and Company...announced that the National Medical Products Administration (NMPA) of China has approved the supplemental New Drug Application (sNDA) for TYVYT® (sintilimab injection) in combination with bevacizumab and chemotherapy (pemetrexed and cisplatin) in patients with epidermal growth factor receptor (EGFR)-mutated non-squamous non-small cell lung cancer (NSCLC) who progressed after EGFR tyrosine kinase inhibitor (TKI) therapy....This new approval in China was based on the results of a randomized, double-blind, multi-center, prospective Phase 3 clinical trial (ORIENT-31, NCT03802240) evaluating TYVYT® (sintilimab injection) ± BYVASDA® (bevacizumab injection) + chemotherapy (pemetrexed and cisplatin)...
Secondary therapy:
cisplatin + pemetrexed
Source:
Title:
Sintilimab plus chemotherapy for patients with EGFR-mutated non-squamous non-small-cell lung cancer with disease progression after EGFR tyrosine-kinase inhibitor therapy (ORIENT-31): second interim analysis from a double-blind, randomised, placebo-controlled, phase 3 trial
Published date:
05/05/2023
Excerpt:
...phase 3 trial was done at 52 centres across China and included patients...EGFR-mutated non-squamous NSCLC...Patients were randomly assigned (1:1:1), using an interactive web response system, to receive sintilimab (200 mg) plus IBI305 (15 mg/kg) plus pemetrexed (500 mg/m2) and cisplatin (75 mg/m2), sintilimab plus chemotherapy, or chemotherapy alone on day 1 of each 3-week cycle for four cycles, followed by maintenance therapy of sintilimab, IBI305, and pemetrexed....Significant progression-free survival benefit was sustained with sintilimab plus IBI305 plus chemotherapy compared with chemotherapy alone (median 7·2 months [95% CI 6·6–9·3]; HR: 0·51 [0·39–0·67]; two-sided p<0·0001).
Secondary therapy:
cisplatin + pemetrexed
DOI:
https://doi.org/10.1016/S2213-2600(23)00135-2
Trial ID:
Source:
Title:
LBA58 - Sintilimab with or without IBI305 plus chemotherapy in patients with EGFR mutated non-squamous non-small cell lung cancer (EGFRm nsqNSCLC) who progressed on EGFR tyrosine-kinase inhibitors (TKIs) therapy: Second interim analysis of phase III ORIENT-31 study
Published date:
09/05/2022
Excerpt:
PFS was significantly improved in Arm B vs Arm C (HR 0.723, 95% CI: 0.552, 0.948; P=0.0181). Confirmed ORR by IRRC was 48.1%, 34.8% and 29.4% in Arm A, B and C respectively; DCR was 86.1%, 81.6% vs 75.6%; median DOR was 8.5 months, 7.4 months vs 5.7 months....Sin combined with or without IBI305 and chemo significantly improved PFS in pts with advanced EGFRm nsqNSCLC who progressed on EGFR-TKI therapy, vs chemo alone.
Secondary therapy:
Chemotherapy
Trial ID:
Source:
Title:
VP9-2021: ORIENT-31: Phase III study of sintilimab with or without IBI305 plus chemotherapy in patients with EGFR mutated nonsquamous NSCLC who progressed after EGFR-TKI therapy
Published date:
11/19/2021
Excerpt:
In pts with EGFRm nsqNSCLC who progressed after EGFR-TKIs, sint combined with IBI305 and chemo has significantly improved PFS compared with chemo alone.
Secondary therapy:
cisplatin + pemetrexed
DOI:
https://doi.org/10.1016/j.annonc.2021.10.007
Trial ID:
Source:
Title:
Sintilimab plus bevacizumab biosimilar IBI305 and chemotherapy for patients with EGFR-mutated non-squamous non-small-cell lung cancer who progressed on EGFR tyrosine-kinase inhibitor therapy (ORIENT-31): first interim results from a randomised, double-blind, multicentre, phase 3 trial
Excerpt:
This randomised, double-blind, multicentre, phase 3 trial was conducted at 52 hospitals in China. Eligible participants were adults aged 18–75 years with locally advanced or metastatic NSCLC and EGFRmut....Participants were randomly assigned (1:1:1) to receive sintilimab (200 mg) plus IBI305 (15 mg/kg) plus pemetrexed (500 mg/m2) and cisplatin (75 mg/m2)....After a median follow-up of 9·8 months (IQR 4·4–13·3), progression-free survival was significantly longer in the sintilimab plus IBI305 plus chemotherapy group versus the chemotherapy alone group (median 6·9 months [95% CI 6·0–9.3] vs 4·3 months [4·1–5·4]; hazard ratio 0·46 [0·34–0·64]; p<0·0001).
Secondary therapy:
Chemotherapy
DOI:
https://doi.org/10.1016/S1470-2045(22)00382-5
Trial ID:
Source:
Title:
Sintilimab ± IBI305 Plus Chemotherapy (Pemetrexed + Cisplatin) for EGFRm + Locally Advanced or Metastasis Non-Squamous NSCLC Patients After EGFR-TKI Treatment Failure
Excerpt:
...Patients with EGFR mutation confirmed by tumor histology or cytology or hematology prior to EGFR-TKI treatmen 5....
