Key Takeaways

• Enhertu® demonstrates significant improvement in progression-free survival for HER2 mutant NSCLC patients versus standard treatments.
• Phase 3 trial findings will be presented at a medical meeting and shared with global regulatory bodies.
• Enhertu is already approved in multiple countries for treating HER2 positive and mutant cancers.

New Hope for Lung Cancer Patients

Positive topline results from the DESTINY-Lung04 phase 3 trial indicate that Enhertu® (trastuzumab deruxtecan) significantly improves progression-free survival (PFS) compared to the global standard of care, which combines platinum-pemetrexed chemotherapy with pembrolizumab. This trial focuses on patients with unresectable, locally advanced, or metastatic HER2 mutant non-squamous non-small cell lung cancer (NSCLC), a population that lacks effective treatment options.

Daiichi Sankyo and AstraZeneca developed Enhertu as a HER2-directed antibody-drug conjugate (ADC). The current treatment landscape for HER2 mutant NSCLC typically involves a combination of immunotherapy and platinum-based chemotherapy, but many patients do not respond or face disease progression, highlighting a critical need for innovative therapies. HER2 mutations, found in 2% to 4% of NSCLC cases, are notably prevalent among younger patients and non-smokers, often leading to poor prognoses and increased brain metastases.

John Tsai, Global Head of R&D at Daiichi Sankyo, stated that Enhertu has already established itself in second-line treatment scenarios for HER2 mutant metastatic NSCLC. The DESTINY-Lung04 trial findings underline Enhertu’s potential to enhance patient outcomes earlier in the treatment process. Similarly, Susan Galbraith, Executive Vice President at AstraZeneca, noted that this trial marks a significant breakthrough, as it is the first phase 3 study to demonstrate a PFS benefit over the standard treatment in this patient cohort.

The safety profile of Enhertu remained consistent with previous reports, with no new safety concerns emerging from the trial data. The study will continue to assess secondary endpoints, including overall survival, to further understand the long-term efficacy and safety of the treatment.

Results from the DESTINY-Lung04 trial will soon be presented at an upcoming medical meeting and submitted to global regulatory authorities for review. Currently, Enhertu holds approval in over 80 countries for patients with HER2 (ERBB2) mutation-positive metastatic NSCLC who have undergone prior therapy.

The DESTINY-Lung04 trial itself is a randomized, open-label study evaluating Enhertu against the standard of care in relevant patient populations. The primary endpoint of PFS is evaluated by independent reviewers, while secondary endpoints cover overall survival and response rates.

Lung cancer remains the most diagnosed cancer globally, with approximately 2.6 million new cases and 1.8 million deaths projected in 2024. For patients diagnosed with metastatic NSCLC, the five-year survival rate is merely around 10%, underscoring the urgency for effective treatment options.

As a next-generation ADC utilizing Daiichi Sankyo’s proprietary DXd technology, Enhertu comprises a HER2 monoclonal antibody fused with a topoisomerase I inhibitor. This groundbreaking treatment has garnered attention for its potential across various HER2-related cancers.

Both Daiichi Sankyo and AstraZeneca are advancing their collaborations to develop and commercialize Enhertu, which could provide much-needed hope for patients battling aggressive forms of cancer with limited existing therapeutic options.

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