Treatment with gotistobart meaningfully improved overall survival (OS) compared with docetaxel among patients with metastatic squamous non\u2013small cell lung cancer (NSCLC), according to findings from the phase 3 PRESERVE-003 trial (NCT05671510) published in Nature Medicine.1<\/p>\n
After a median follow-up of 14.5 months (range, 0.1-18.8), the median OS was not reached (NR; 95% CI, 9.3 months to not evaluable [NE]) with gotistobart vs 10.0 months (95% CI, 6.2-11.9) with docetaxel (HR, 0.46; 95% CI, 0.25-0.84; P = .0102). Data showed 12-month OS rates of 63.1% (95% CI, 46.9%-75.5%) vs 30.3% (95% CI, 16.2%-45.6%) in each respective arm.<\/p>\n
Investigators reported a median progression-free survival (PFS) of 2.4 months (95% CI, 2.1-4.5) with gotistobart and 2.6 months (95% CI, 2.1-3.9) with docetaxel; a trend towards favorable PFS was noted in the experimental arm (HR, 0.69; 95% CI, 0.42-1.13). Additionally, the confirmed objective response rate (ORR) was 20.0% (95% CI, 9.6%-34.6%) and 4.8% (95% CI, 0.6%-16.2%) in each arm, with respective median duration of responses (DORs) of 11.0 months (95% CI, 3.5-NE) and 3.8 months (95% CI, 3.6-NE).<\/p>\n
OS and PFS outcomes were numerically higher with docetaxel vs gotistobart among patients with nonsquamous NSCLC who received the experimental agent at 6 mg\/kg every 3 weeks with 2 loading doses of 10 mg\/kg, supporting the data monitoring committee\u2019s recommendation to halt clinical development for the nonsquamous population. Additionally, poor outcomes in patients with squamous or nonsquamous disease who received gotistobart at 3 mg\/kg every 3 weeks supported the data monitoring committee\u2019s recommendation to terminate the low-dose cohort.<\/p>\n
\u201cThis randomized study demonstrates a clinically meaningful improvement in OS with a novel immunotherapy monotherapy compared to docetaxel in patients with [squamous] NSCLC who experience disease progression on or after anti\u2013PD-(L)1 treatment, given either in combination with or after [platinum-based chemotherapy],\u201d lead study author Byoung Chul Cho, MD, PhD, from the Division of Medical Oncology at Yonsei Cancer Center in Seoul, South Korea, wrote with coauthors in the publication.1 \u201c[W]ith a 54% reduction in the risk of death over docetaxel and manageable toxicity, the results from the nonpivotal stage 1 of this phase 3 randomized study suggest that gotistobart may offer a chemotherapy-free treatment option to transform the treatment paradigm of [squamous] NSCLC with better outcomes for patients.\u201d<\/p>\n
In stage 1A of the 2-stage, open-label PRESERVE-003 trial, 120 patients were randomly assigned 1:1:1 to receive to gotistobart at 3 mg\/mg every 3 weeks, gotistobart at 6 mg\/kg with 2 loading doses of 10 mg\/kg every 3 weeks, or docetaxel at 75 mg\/m2 every 3 weeks. As part of the ongoing stage 2 portion of the trial, patients with squamous disease were randomly assigned 1:1 to receive gotistobart at 6 mg\/kg or docetaxel.<\/p>\n
The trial\u2019s primary end point was OS. Secondary end points included investigator-evaluated PFS and ORR per RECIST v1.1 criteria, as well as safety.<\/p>\n
Patients 18 years and older with histologically or cytologically confirmed metastatic squamous NSCLC, radiographic progression after treatment on the most recent line of therapy, and at least 1 measurable lesion per RECIST v1.1 guidelines were eligible for enrollment on the trial.2 Additional requirements for study entry included having an ECOG performance status of 0 or 1, adequate organ function, and a life expectancy of at least 3 months.<\/p>\n
Among 45 patients who received gotistobart and 42 who received docetaxel, respectively, the median age was 64.0 years (range, 39-86) and 68.5 years (range, 43-84), and most patients from each arm were male (80.0% vs 90.5%) and Asian (71.1% vs 71.4%). Additionally, most patients from each arm had an ECOG performance status of 1 (80.0% vs 83.3%), former smoking status (75.6% vs 64.3%), and 1 prior line of treatment in the advanced or metastatic setting (66.7% vs 71.4%).<\/p>\n
Adverse effects (AEs) of any grade occurred in 84.4% of patients in the gotistobart arm and 90.2% of those in the docetaxel arm, with 42.2% and 48.8% experiencing grade 3 or higher AEs, respectively. The most common any-grade AEs in the gotistobart arm included increased alanine aminotransferase (28.9% vs 9.8%), diarrhea (28.9% vs 9.8%), and increased aspartate aminotransferase (26.7% vs 4.9%).<\/p>\n
Serious AEs related to study treatment were noted in 42.2% of the gotistobart arm and 29.3% of the docetaxel arm. The most common serious AEs included colitis (11.1%), immune-mediated lung disease (6.7%), and pneumonia (4.4%) in the gotistobart arm and pneumonia (9.8%) and febrile neutropenia (7.3%) in the docetaxel arm.<\/p>\n
ReferencesCho BC, Balaraman R, Chen H-J, et al. Gotistobart or docetaxel in metastatic squamous non-small cell lung cancer: stage 1 of the randomized phase 3 PRESERVE-003 trial. Nat Med. Published online March 27, 2026. doi:10.1038\/s41591-026-04323-8ONC-392 versus docetaxel in metastatic NSCLC that progressed on PD-1\/\u200bPD-L1 inhibitors (PRESERVE-003). ClinicalTrials.gov. Updated February 25, 2026. Accessed April 8, 2026. https:\/\/tinyurl.com\/5487pt8v <\/p>\n","protected":false},"excerpt":{"rendered":"Treatment with gotistobart meaningfully improved overall survival (OS) compared with docetaxel among patients with metastatic squamous non\u2013small cell…\n","protected":false},"author":2,"featured_media":369726,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[10],"tags":[134,111,139,69],"class_list":{"0":"post-369725","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-health","8":"tag-health","9":"tag-new-zealand","10":"tag-newzealand","11":"tag-nz"},"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/nz\/wp-json\/wp\/v2\/posts\/369725","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/nz\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/nz\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/nz\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/nz\/wp-json\/wp\/v2\/comments?post=369725"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/nz\/wp-json\/wp\/v2\/posts\/369725\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/nz\/wp-json\/wp\/v2\/media\/369726"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/nz\/wp-json\/wp\/v2\/media?parent=369725"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/nz\/wp-json\/wp\/v2\/categories?post=369725"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/nz\/wp-json\/wp\/v2\/tags?post=369725"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}