Biotech Values

[dangerM]

AZN PACIFIC 16.8M OS with drug vs 5.6M in placebo in stage 3 NSCLC

AstraZeneca rebuilds cancer drug hopes with new lung data
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Analysts believe using Imfinzi in so-called stage III lung cancer opens up an annual sales opportunity worth around $2 billion. The company also has an important lead of two to three years over rivals in this particular area.

However, this market is still smaller than for advanced lung cancer, where a combination of Imfinzi and tremelimumab failed to work as hoped in the Mystic trial.
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source: https://in.reuters.com/article/us-health-cancer-astrazeneca/astrazeneca-rebuilds-cancer-drug-hopes-with-new-lung-data-idINKCN1BJ2NQ

Late-breaker abstract:
http://194.224.142.195/slidecenter/esmo2017/confcal/pacific

LBA1_PR - PACIFIC: A double-blind, placebo-controlled phase III study of durvalumab after chemoradiation therapy (CRT) in patients with stage III, locally advanced, unresectable NSCLC
L. Paz-Ares ...

Background

Most patients (pts) with locally advanced, unresectable non-small cell lung cancer (NSCLC) progress despite concurrent chemoradiation therapy (cCRT). Here we report interim results from a global, Phase 3 study (NCT02125461) of the anti-PD-L1 durvalumab as consolidation therapy in Stage III pts without progression following platinum-based cCRT.

Methods

Pts with a WHO performance status 0/1 (any PD-L1 status) who received ≥2 cycles of platinum-based cCRT without progression were randomized (2:1) 1–42 days post-cCRT to receive durvalumab 10?mg/kg IV Q2W or placebo for up to 12 months, stratified by age, sex, and smoking history. Co-primary endpoints were progression-free survival (PFS; blinded independent central review, RECIST v1.1) and overall survival (OS). Secondary endpoints included 12- and 18-month PFS rates, objective response rate (ORR), duration of response (DoR), time to death or distant metastasis (TTDM) and safety.

Results

Between May 2014 and April 2016, 713 pts were randomized of whom 709 received consolidated treatment (durvalumab, n?=?473; placebo, n?=?236). Baseline characteristics were well balanced. As of Feb 13, 2017 (data cutoff), median follow-up was 14.5 months. Median PFS from randomization was significantly longer with durvalumab (16.8 months, 95% CI, 13.0–18.1) versus placebo (5.6 months, 95% CI, 4.6–7.8; stratified HR 0.52, 95% CI, 0.42–0.65; P?<?0.0001). 12- and 18-month PFS rates were 55.9% versus 35.3% and 44.2% versus 27.0%, respectively. ORR was higher (28.4% vs 16.0%; P?<?0.001) and median DoR was longer (not reached vs 13.8 months) with durvalumab consolidation therapy. Median TTDM was longer with durvalumab (23.2 vs 14.6 months; stratified HR 0.52, 95% CI, 0.39–0.69; P?<?0.0001). OS data were immature at the time of interim PFS analysis. Comparing durvalumab with placebo, grade 3/4 adverse events (AEs) occurred in 29.9% and 26.1%; most common was pneumonia (4.4% vs 3.8%). 15.4% and 9.8% discontinued due to AEs.

Conclusions

Durvalumab demonstrated significant and clinically meaningful improvement in PFS, which was supported by secondary endpoints, and was well tolerated. Durvalumab is a promising therapeutic option in this setting.