IMFINZI is a programmed death-ligand 1 (PD-L1) blocking antibody indicated...for the treatment of adult patients with unresectable, Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.

AstraZeneca today announced that it has received marketing authorisation from China’s National Medical Products Administration (NMPA) for Imfinzi (durvalumab) for the treatment of patients with unresectable, Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (CRT).

Recommendation 5.7....Patients with stage III NSCLC receiving concurrent chemoradiation without disease progression during the initial therapy should be offered consolidation durvalumab for up to 12 months (Type: Evidence based; benefit outweighs harm; Evidence quality: high; benefit outweighs harm; Strength of recommendation: strong).

The NCCN NSCLC Panel recommends durvalumab (category 1) as consolidation immunotherapy (regardless of PD-L1 status)...

The consolidation administration of the immune checkpoint inhibitor durvalumab (human anti PD-L1 antibody), 1 to 42 days after the end of chemoradiotherapy (10 mg/kg every 2 weeks for up to 12 months) has demonstrated a survival benefit in stage III unresectable NSCLC and is recommended [A [ 1005 and I, A]

118 (71.5%) pts received D maintenance, with mOS of 16.6 mo. 85 (51.5%) pts received >4 EP cycles, with mOS of 17.4 mo (Table). mPFS was 6.3 mo (mFU 8.6 mo). ORR was 76.4%, with 3 (1.8%) complete responses...Final results of ORIENTAL showed in the largest to date, real-world-like Chinese ES-SCLC cohort that D+EP was effective and well tolerated, further supporting D+EP as 1L SoC in China.

Positive high-level results from a planned interim analysis of the AEGEAN Phase III, placebo- controlled trial showed that treatment with AstraZeneca’s Imfinzi (durvalumab) in combination with neoadjuvant chemotherapy before surgery and as adjuvant monotherapy after surgery demonstrated a statistically significant and clinically meaningful improvement in event-free survival (EFS) versus neoadjuvant chemotherapy alone followed by surgery for patients with resectable early-stage (IIA-IIIB) non-small cell lung cancer (NSCLC).

Positive high-level results from a planned interim analysis of the AEGEAN Phase III trial showed treatment with AstraZeneca’s Imfinzi (durvalumab) in combination with neoadjuvant chemotherapy before surgery demonstrated a statistically significant and meaningful improvement in pathologic complete response (pCR) compared to neoadjuvant chemotherapy alone for patients with resectable non-small cell lung cancer (NSCLC).

Updated results from the positive PACIFIC Phase III trial showed AstraZeneca’s Imfinzi (durvalumab) demonstrated a sustained, clinically meaningful overall survival (OS) and progression-free survival (PFS) benefit at five years in patients with unresectable, Stage III non-small cell lung cancer (NSCLC)...Results...showed an estimated five-year OS rate of 42.9% for patients treated with Imfinzi versus 33.4% for those on placebo after CRT. Median OS was 47.5 months for Imfinzi versus 29.1 for placebo.

Overall, 709/713 randomized patients received durvalumab (n/N=473/476) or placebo (n/N=236/237)….These updated, exploratory analyses demonstrate durable PFS and sustained OS benefit with durvalumab following CRT. An estimated 49.6% of patients randomized to durvalumab remain alive at 4 years (placebo, 36.3%), and 35.3% remain alive and progression free (placebo, 19.5%).

...patients (pts) with unresectable Stage III NSCLC...The 48-month OS rates were 49.6% vs 36.3% for durvalumab vs pbo, and PFS rates were 35.3% vs 19.5% respectively....

AstraZeneca's Imfinzi (durvalumab) has received acceptance for its supplemental Biologics License Application (sBLA) and has also been granted Priority Review in the US for a new four-week, fixed-dose regimen for treatment in the approved indications of non-small cell lung cancer (NSCLC) and bladder cancer.

...patients with stage III, unresectable non–small-cell lung cancer (NSCLC)...The 24-month overall survival rate was 66.3% (95% confidence interval [CI], 61.7 to 70.4) in the durvalumab group, as compared with 55.6% (95% CI, 48.9 to 61.8) in the placebo group (two-sided P=0.005). Durvalumab significantly prolonged overall survival, as compared with placebo (stratified hazard ratio for death, 0.68; 99.73% CI, 0.47 to 0.997; P=0.0025)....Durvalumab therapy resulted in significantly longer overall survival than placebo.

This phase 3 study compared the anti–programmed death ligand 1 antibody durvalumab as consolidation therapy with placebo in patients with stage III NSCLC...Progression-free survival was significantly longer with durvalumab than with placebo.

AstraZeneca and MedImmune, its global biologics research and development arm, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for Imfinzi (durvalumab) for the treatment of patients with locally-advanced, unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemoradiation therapy.

Updated OS data from PACIFIC, including 3-year survival rates, demonstrate the long-term clinical benefit with durvalumab after chemoradiotherapy and further establish the PACIFIC regimen as the standard of care in this population.