ADRIATIC Trial Demonstrates Significant Survival Benefit in LS-SCLC, Potentially Shaping Future Treatment Standards

PE: The ADRIATIC trial demonstrated significant survival benefits for LS-SCLC patients. How do you envision this approval changing the standard treatment paradigm for these patients?

Ghattas: LS-SCLC is an aggressive form of lung cancer where we’ve seen a poor prognosis. Around 15% to 30% of patients were alive five years post-diagnosis. For the last 40 years or so, this treatment landscape has remained unchanged, and now for the first time, we see with ADRIATIC a huge advancement. It’s a significant breakthrough that addresses a huge unmet need.

ADRIATIC has the potential for making Imfinzi (durvalumab) new standard of care, especially in the earlier stage, limited-stage small cell lung cancer with the curative intent in mind. This has also been endorsed by the NCCN guidelines as category number one.

PE: What key design elements of the ADRIATIC Phase III trial contributed most to its success, especially considering the challenges with past trials in LS-SCLC?

Ghattas: The ADRIATIC trial has been very robust, and it built on our key learnings that we've seen with Imfinzi in previous studies in small cell lung cancer, especially with the role of Imfinzi in post-chemo radiotherapy. With the approval from ADRIATIC, Imfinzi has now been extended to be used in limited-stage small cell lung cancer, as well as extensive-stage small cell lung cancer within the United States.

Full Interview Summary: The approval of Imfinzi represents a landmark advancement in the treatment of limited-stage small cell lung cancer (LS-SCLC), a highly aggressive cancer with historically poor outcomes. For decades, the treatment paradigm for LS-SCLC has remained stagnant, with only 15–30% of patients surviving five years post-diagnosis. The trial demonstrated impressive results, with Imfinzi improving median overall survival to 55.9 months compared to 33.4 months with placebo—a nearly 22-month survival benefit. These outcomes highlight the benefits of early diagnosis and treatment in a curative-intent setting, solidifying Imfinzi as a potential new standard of care endorsed by NCCN guidelines as a Category 1 option.

The robust design of the ADRIATIC Phase III trial was key to its success, leveraging insights from prior studies on Imfinzi in extensive-stage SCLC and incorporating its use post-chemoradiotherapy. This strategy ensured optimal progression-free and overall survival outcomes, extending Imfinzi’s utility to LS-SCLC.

While Imfinzi is already approved in the U.S. and Switzerland, AstraZeneca is focused on securing regulatory approvals in other regions, including the EU and Japan. The unprecedented data from the ADRIATIC Phase III trial, coupled with AstraZeneca’s collaboration with regulatory authorities, is expected to expedite global access.

Looking ahead, AstraZeneca aims to innovate further in immuno-oncology, with priorities in redefining standards of care for early-stage cancers and improving survival outcomes for hard-to-treat malignancies. The company remains committed to advancing its robust pipeline and developing novel therapies to transform cancer care.