The AstraZeneca plc (LON: AZN) share price alternated between gains and losses after issuing an update regarding the PACIFIC-2 Phase III trial involving Imfinzi (durvalumab) in combination with platinum-based chemoradiotherapy (CRT) for the treatment of unresectable, Stage III non-small cell lung cancer (NSCLC).
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The data collected indicates that the trial did not meet the statistical significance threshold for its primary endpoint, progression-free survival (PFS), compared to CRT alone.
Currently, the established global standard of care for unresectable Stage III NSCLC involves the sequential administration of Imfinzi following platinum-based CRT, based on the PACIFIC Phase III trial findings.
The PACIFIC-2 trial was initiated to explore the concurrent administration of Imfinzi with CRT, aiming to address the needs of patients who experience disease progression or discontinue treatment during CRT, making them ineligible for the standard PACIFIC regimen.
An initial analysis of the safety and tolerability of Imfinzi and CRT in this patient population indicated that their safety profiles were broadly consistent with the known characteristics of these treatments. However, it's worth noting that an increased incidence of infections was observed during the concurrent treatment phase in the experimental arm.
Despite the results from PACIFIC-2, AstraZeneca continues to pursue multiple registrational trials involving Imfinzi for various stages of lung cancer.
The trials include testing Imfinzi in resectable NSCLC (ADJUVANT BR.31), medically inoperable or unresected Stage I-II NSCLC (PACIFIC-4), unresectable, Stage III NSCLC (PACIFIC-5, 8, and 9), and limited-stage small-cell lung cancer (SCLC) (ADRIATIC).
Jeffrey D. Bradley, MD, principal investigator for the trial, said: “While the PACIFIC-2 trial results did not show what we hoped, the PACIFIC regimen remains the standard of care for patients with unresectable, Stage III non-small cell lung cancer. As a community, we will take insights from these results to advance future research.”
Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “Our goal with the PACIFIC-2 trial was to address a remaining unmet need for patients in this setting by introducing immunotherapy even earlier and concurrently administering Imfinzi with chemoradiotherapy. While today's results did not reach statistical significance, we will learn from this trial, and we remain committed to improving patient outcomes by expanding the benefit of immunotherapy to lung cancer patients across treatment settings.”
AstraZeneca (AZN) share price.
After today's clinical trial update, the AstraZeneca share price alternated between gains and losses.
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