AZN Ends NSCLC Study for Bispecific Antibody Over Unlikely Success

This decision comes after an independent committee conducted a planned review of the study data and concluded that the volrustomig combination was unlikely to achieve either of the dual primary endpoints, progression-free survival (PFS) or overall survival (OS), versus the comparator arm. The review did not identify any new safety concerns associated with the drug.

Despite this setback, AstraZeneca is not ending the development of volrustomig and intends to continue the other late-stage studies evaluating the candidate in cervical cancer, head and neck squamous cell carcinoma and mesothelioma.

Another Pipeline Setback for AstraZeneca

The eVOLVE-Lung02 setback marks the third clinical setback reported by AstraZeneca in less than two months.

The first came in early July when AstraZeneca announced the failure of a phase III study evaluating one of its newer drugs, Wainua (eplontersen), in patients with transthyretin-mediated amyloid cardiomyopathy (ATTR-CM).

This was followed by a setback for its blockbuster drug, Ultomiris (ravulizumab), which failed to achieve statistical significance on the primary endpoint in a late-stage study for patients with hematopoietic stem cell transplantation-associated thrombotic microangiopathy (HSCT-TMA).

However, AstraZeneca’s shares closed 0.3% higher on Monday despite the eVOLVE-Lung02 setback. The decision to continue developing volrustomig in other cancer indications, along with positive readouts from two separate phase III NSCLC studies, helped offset the disappointment from the discontinued study.

Year to date, the stock has lost 15% against the industry’s 4% growth.

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Positive NSCLC Readouts Lift AZN Stock

Adding to the positive sentiment were encouraging results from two separate late-stage studies in NSCLC. One evaluated the combination of AstraZeneca’s blockbuster EGFR inhibitor Tagrisso (osimertinib) with Orpathys (savolitinib), a MET-TKI partnered with Hutchmed HCM. The other evaluated Enhertu (trastuzumab deruxtecan).

The SAFFRON study showed that Tagrisso plus Orpathys delivered statistically significant and clinically meaningful improvements in both PFS and OS compared with platinum-based chemotherapy. The study evaluated patients with EGFR-mutated NSCLC whose tumors had high levels of MET overexpression or amplification and whose disease had progressed following prior Tagrisso treatment. Per AstraZeneca, these results represent the first global phase III study to demonstrate both PFS and OS benefits in this setting.

The positive results are important for AstraZeneca as they support the potential for extending Tagrisso’s role in EGFR-mutated NSCLC after disease progression. MET overexpression or amplification is one of the common mechanisms of resistance to third-generation EGFR-TKIs, creating a need for targeted treatment options in this setting.

A selective MET inhibitor, Orpathys is yet to be approved by the FDA. It is currently approved in China for certain NSCLC indications.

The DESTINY-Lung04 study evaluated Enhertu as the first-line treatment for patients with unresectable, locally advanced or metastatic HER2-mutant non-squamous NSCLC. The results showed that the drug significantly improved PFS when compared with the combination of Merck’s Keytruda and platinum-pemetrexed doublet chemotherapy, which is considered the global standard of care. The study will continue to evaluate OS and other secondary endpoints.

Taken together, the two positive readouts provide some reassurance for AstraZeneca’s lung cancer franchise, although both address relatively targeted segments of the broader NSCLC market. The SAFFRON results could support additional treatment options for patients who progress on Tagrisso, while DESTINY-Lung04 could expand Enhertu’s use into first-line treatment. However, the latter opportunity is more limited in scope, given that HER2 mutations occur in only around 2-4% of patients with non-squamous NSCLC.

AZN’s Zacks Rank

AstraZeneca currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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