Daiichi Sankyo and Merck Announce Positive Phase II Results of B7-H3 ADC Ifinatamab Deruxtecan in Extensive-Stage Small Cell Lung Cancer
Daiichi-Sankyo
Pharmaceutical R&D Developer
MSD
Pharmaceutical R&D and Manufacturer
On September 7 local time, Daiichi Sankyo and MSD orally presented Ifinatamab Deruxtecan at the 2025 WCLC Conference.(I-DXd)TreatmentExtensive-Stage Small Cell Lung CancerThe primary analysis results of the Phase II IDeate-Lung01 study.
Screenshot source: Company official website
Ifinatamab deruxtecan is aPotential FirstAn ADC targeting B7-H3. The drug is designed using Daiichi Sankyo's proprietary DXd ADC technology, consisting of a humanized anti-B7-H3 IgG1 monoclonal antibody linked via a cleavable tetrapeptide linker to multiple topoisomerase I inhibitor payloads.(A derivative of exatecan, DXd)Composed of connections. The drug is manufactured byDaiichi-SankyoDeveloped byDaiichi Sankyo and MSD Collaborate on Development。
IDeate-PanTumor01 is a global, multicenter, first-in-human, open-label Phase I/II clinical trial designed to evaluate the safety and efficacy of Ifinatamab deruxtecan in patients with advanced/unresectable or metastatic solid tumors who are non-responsive or intolerant to standard treatments, or for whom no standard treatment options are available.
As of March 3, 2025, in the dose optimization and extension part, 137 patients received I-DXd 12 mg/kg as a second-line treatment.（23.4%）, Third Line（54.7%）Or four-line（21.9%）Treatment(Median follow-up time was 12.8 months)。
The results showed that, after blinded independent central review (BICR) Evaluation, in 137 patients with previously treated ES-SCLC,The confirmed ORR was 48.2%.（95% CI，39.6-56.9），DCR is 87.6%（95% CI，80.9-92.6），Median DOR was 5.3 months（95% CI，4.0-6.5），Median TTR For 1.4 months(Range, 1.0-8.1)，Median PFS and median OS were 4.9 months, respectively.（95% CI，4.2-5.5）And10.3 months（95% CI，9.1-13.3）。
UndergoingIfinatamab deruxtecan Among the 32 patients as second-line treatment, confirmed by BICR assessmentORR was 56.3%（95% CI：37.7-73.6）In this group of patients, 18 had PR and 13 had SD. The median DOR was 7.2 months.（95% CI：3.6-NE）, DCR was 96.9%（95% CI：83.8-99.9）The median PFS was 5.6 months.（95% CI：3.9-8.1）, with a median OS of 12.0 months（95% CI：7.3-19.1）。
UndergoingIfinatamab deruxtecan In the subgroup of patients receiving third-line or higher treatment（n=105）, ConfirmedORR was 45.7%（95% CI: 36.0-55.7）Among them, 3 cases of CR, 45 cases of PR, 41 cases of SD, and the DCR was 84.8%.（95% CI: 76.4-91.0）。
An exploratory analysis showed that there was a subgroup of 65 patients with brain metastases at baseline.（n=65）In China, according to CNS RECIST v1.1 observedIntracranial ORR was 46.2%（95% CI: 33.7-59.0）. Complete subgroup analysis（2760MO）The results will be presented at the ESMO Congress 2025.
In terms of safety, the safety of IDeate-Lung01 is consistent with that of Ifinatamab deruxtecan in Phase I trials, with no new safety signals identified.
36.5% of patients experienced treatment-related adverse events of grade 3 or higher. (TRAE). The most common（> 10%）TRAE of Grade 3 or higher isNeutropenia, lymphocytopenia, and anemia. Interstitial lung disease related to treatment was confirmed by an independent adjudication committee in 17 patients. (ILD)/ Pneumonia. Most ILD/pneumonia events were low-grade, and as of the data cutoff date of March 3, 2025, 11 grade 1 or 2 events were observed.（8.0%）, 4 cases of Grade 3（2.9%）And 2 to 5 levels（1.5%）ILD/Pneumonia Event.
Screenshot source: Corporate official website
