Onco-Summaries: Daily Oncology Updates at a Glance
Updated: 11 hours ago
14/09/2026
US FDA reduces IMDELLTRA monitoring time to 6–8 hours, expanding Community Oncology Access (Ref)
Amgen announced that the US FDA has approved a reduction in monitoring time for the first two doses of IMDELLTRA® (tarlatamab-dlle; DLL3-targeted bispecific T-cell engager) in patients with extensive-stage small cell lung cancer (ES-SCLC)
Monitoring time reduced from 22–24 hours to 6–8 hours for the first two doses
Patients must still undergo assessments the day after each of these doses
Patient Impact: Eases treatment burden, allowing care closer to home and simplifies administration in community oncology settings, where most US cancer patients are treated
Reduced monitoring is being evaluated in broader studies; Amgen recently reported positive Phase 3 survival data in first-line ES-SCLC
BioNTech & Onco4's gotistobart doubled mOS vs docetaxel in non-pivotal part of the Ph3 PRESERVE-003 trial (Ref1, Ref2)
In the updated outcomes from the non-pivotal Stage 1 of the Ph3 PRESERVE-003 trial presented at WCLC'26, BioNTech & Onco4's gotistobart (a CTLA-4 CTLA-4 Treg-depleting mAb) monotherapy nearly doubled median OS vs docetaxel in ≥2L squamous pts (Ref1, Ref2)
At mFU of 25.4 mos, the regimen showed a statistically significant and clinically meaningful OS benefit, with median OS of 18.5 mos vs 10.0 mos (HR 0.56; p=0.0295) in sq- pts in the gotistobart (n=45) vs docetaxel arms (n=42). The first-time numerical OS data presented here remain consistent with the earlier published detailed outcomes from Stage 1 (Nature Medicine; Ref), in which mOS was NR vs 10.0 mos (HR 0.46; p=0.0102). The safety profile of gotistobart remained consistent with previously reported outcomes, with Gr≥3 TRAEs seen in 44.4% vs 48.8% of pts, but when compared to AEs seen in ≥2L IO regimens, gotistobart's AEs rank higher (SOC IO Gr≥3 TRAEs ~15%).
If the Stage 1 OS signal is replicated in the pivotal Stage 2 portion of PRESERVE-003, gotistobart could potentially establish a chemotherapy-free treatment option in the ≥2L sqNSCLC setting, subject to regulatory approval. The trial is ongoing, with the first interim analysis of the Stage 2 pivotal portion expected in H2'26 (Ref), and gotistobart is estimated to launch in H2'27 (fastest-case scenario)
US FDA grants Breakthrough Therapy Designation to RASONQUE™ (daraxonrasib) + chemotherapy for first‑line metastatic pancreatic cancer (Ref)
Revolution Medicines announced that the US FDA has granted Breakthrough Therapy Designation to RASONQUE™ (daraxonrasib; RAS(ON) inhibitor) in combination with gemcitabine + nab-paclitaxel for first-line treatment of metastatic pancreatic adenocarcinoma (PDAC)
The Breakthrough Therapy Designation is supported by Phase 1/2 RMC-GI-102 trial showing encouraging antitumor activity and manageable safety in treatment‑naïve RAS mutant PDAC
These data informed the design of RASolute 303, the ongoing global Phase 3 trial evaluating RASONQUE as monotherapy and in combination with GnP versus GnP alone in patients with previously untreated metastatic PDAC, independent of tumor RAS genotype
In the Ph3 DESTINY-Lung04 trial, trastuzumab deruxtecan improved median PFS by 6 months vs pembro + chemo, in 1L HER2-mutant NSCLC pts (abstract #PL03.08; Ref)
First-time efficacy and safety from the Ph3 DESTINY-Lung04 trial of AstraZeneca and Daiichi Sankyo’s trastuzumab deruxtecan (Enhertu; HER2 ADC) vs pembro + platinum-pemetrexed doublet chemo in the Tx of unresectable LA/M first-line non-squamous patients with HER2 Exon 19 or 20 mutations was presented during the Presidential Symposium at WCLC 2026.
At median follow-up of 21.7 mos in the T-DXd arm and 20.4 mos in the pembro arm, following results were observed: (Ref)
*At the time of analysis, the OS data were 46.9% mature and no formal hypothesis testing was performed
Safety was comparable between the two arms, with Gr ≥3 TRAEs seen in 34.1% vs 33.6% in either arms.
Positive efficacy outcomes elicited by zidesamtinib in TKI-naive ROS1+ NSCLC may support potential expansion to first-line Tx (abstract #PL03.06; Ref)
Positive results from the registrational Ph1/2 ARROS-1 trial of GSK's zidesamtinib (Jideytro; ROS1 selective inhibitor) in patients with advanced or metastatic ROS1+ who were TKI-naïve with upto 1 prior line of chemo and/or immunotherapy was presented at the Presidential Symposium at WCLC 2026
At mFU of 15.2 mos, zidesamtinib elicited an ORR of 93.6% (95% CI 87-98), including a 14.9% CR in all efficacy evaluable pts (N=94). Median PFS and DOR had not been reached at the time of analysis, and 1-yr PFS rate was 90%. All pts with brain metastases (n=10) responded to the Tx, with 70% pts achieving complete clearance of detectable brain tumours.
Data will support a planned supplemental NDA submission in 2026, to expand zidesamtinib to first-line setting (Ref)
Earlier this year, the US FDA approved zidesamtinib for the Tx of ROS1 inhibitor experienced ROS1+ , based on results from the ARROS-1 study.
Hengrui’s HER3 ADC Receives China Breakthrough Therapy Designation in Post-TKI EGFR-Mutant NSCLC (Ref)
Hengrui's Ruzaltatug Rezetecan (SHR-A2009; HER3-targeted ADC) has been granted Breakthrough Therapy Designation (BTD) by China's NMPA/CDE for use in combination with bevacizumab in patients with locally advanced or metastatic non-squamous NSCLC harboring EGFR mutations whose disease has progressed following EGFR TKI treatment
Comments