Phase 3 EVOKE-01 Study in Metastatic NSCLC Falls Short of Primary Endpoint


Researchers from Gilead remain confident for positive results as they continue the phase 3 EVOKE-03 study in 1L metastatic PD-L1-high NSCLC.

Researchers announced that the phase 3 EVOKE-01 study evaluating sacituzumab govitecan-hziy (SG) (Trodelvy, Gilead Sciences, Inc) did not meet the primary endpoint of overall survival (OS) among individuals treated for metastatic non-small cell lung cancer (NSCLC).

Non Small Cell Lung Cancer (NSCLC) in the lung tissue – isometric view 3d illustration - Image credit: LASZLO |

Image credit: LASZLO |

NSCLC is reported to be the most common type of lung cancer worldwide, with nearly 85% of diagnoses out of 2 million cases of lung cancer. Among individuals diagnosed with NSCLC, 57% of cases are already at the metastatic stage at time of diagnosis, according to study authors. However, even with an early diagnosis, half of NSCLC cases will develop to metastatic NSCLC over a 5-year period.

The EVOKE-01 study was a global, multi-center, open-label phase 3 study that assessed SG compared to docetaxel in individuals with advanced or metastatic NSCLC that continued treatment during or after platinum-based chemotherapy and checkpoint inhibitor therapy.

According to study authors, SG is a first-in-class Trop-2-directed antibody-drug conjugate. SG was created with a “proprietary hydrolyzable linker attached to SN-38, a topoisomerase I inhibitor payload.”

The study included 603 individuals with a primary endpoint of OS and secondary endpoints of progression-free survival (PFS), objective response rate (ORR), duration of response (DoR) and disease control rate (DCR).

Despite not meeting the primary endpoint, the study authors noted that an improvement in OS supporting SG was seen among individuals with squamous and non-squamous histology. A subgroup of individuals who were non-responsive to a previous anti-PD-(L)1 therapy showed a difference in median OS favoring SG, in more than a 3-month period. However, the study authors noted that the difference was not present in the subgroup of individuals who responded to the previous anti-PD-(L)1 therapy.

“The totality of our data gives us continued confidence in Trodelvy’s potential in metastatic NSCLC, and in our broader lung cancer clinical development program,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences, in a press release. “Treating metastatic NSCLC that has progressed on or after platinum-based chemotherapy presents significant challenges and the need for safe and effective treatments remains urgent. We will work to further identify the metastatic NSCLC patient populations that may benefit from Trodelvy.”

The study authors noted that SG was well tolerated and the safety profile remained consistent with previous studies with no new concerns.

SG has not yet been approved to treat individuals with metastatic NSCLC and its safety and efficacy has not yet been identified for these patients.

However, the study authors noted that Gilead will continue their research. The organization stated that they are hopeful for positive results as they continue the phase 3 EVOKE-03 study in 1L metastatic PD-L1 high NSCLC.

Gilead Provides Update on Phase 3 EVOKE-01 Study. Gilead. News release. January 22, 2024. Accessed February 12, 2024.

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