Onco-Summaries: Daily Oncology Updates at a Glance
- Oncofocus Team
- 2 hours ago
- 4 min read
31/08/2026
MT027 secures US FDA Fast Track designation for recurrent Glioblastoma (Ref)
T-MAXIMUM Pharmaceutical ("T-MAXIMUM") announced that MT027 (allogeneic CAR-T cell therapy) has been granted Fast Track Designation (FTD) by the US FDA for the treatment of recurrent glioblastoma
MT027 had previously been granted the FDA Orphan Drug Designation (ODD) for the treatment of recurrent high-grade glioma, and clearance from the FDA to conduct a Phase 2 clinical study in recurrent glioblastoma
Development is extending into brain metastases and other solid tumors suitable for local delivery, with preliminary first‑in‑human data expected at WCLC September 2026
FDA clears IDEAYA’s IDE849 Phase 3 path in ES-SCLC (Ref)
IDEAYA Biosciences announced a successful FDA Type C meeting to determine the Phase 3 registrational trial design for IDE849 (DLL3-targeting TOP1 ADC) in extensive-stage small cell lung cancer (ES-SCLC)
The FDA has agreed to the Phase 3 registrational trial design and the agreement provides a pathway for both accelerated and full approval
Trial Design:
~400 ES-SCLC patients randomized 1:1 (IDE849 vs. investigator’s choice: topotecan/amrubicin)
Accelerated approval endpoint: Objective response rate (ORR) by blinded independent central review
Full approval endpoint: Median overall survival (OS)
Dose evaluation is ongoing for 2.4mg/kg and 3.5 mg/kg IV Q3W to determine the RP3D
IDE849 is being evaluated in clinical combinations with PDL1 and IDEAYA's PARG inhibitor IDE161 to determine a potential 1L SCLC Phase 3 registrational trial design
Upcoming Readouts:
Partner Hengrui to present data in ~100 ES-SCLC/NEC patients at ESMO 2026.
IDEAYA-sponsored Phase 1/2 update expected in Q4 2026
In Phase 3 HERIZON-GEA-01 trial, ZIIHERA + chemotherapy demonstrated a statistically significant improvement in OS vs trastuzumab + chemotherapy, meeting the primary endpoint (Ref)
Positive topline results from the second interim analysis (IA2) of the Phase 3 HERIZON-GEA-01 trial evaluating Jazz, BeOne and Zymeworks' Ziihera (zanidatamab-hrii; bispecific HER2-directed antibody) in combination with chemotherapy with and without BeOne's tislelizumab (anti-PD-1) as first-line treatment for HER2+ locally advanced or metastatic gastroesophageal adenocarcinoma (GEA) was reported
ZIIHERA + chemotherapy showed a statistically significant overall survival (OS) benefit versus trastuzumab + chemotherapy, meeting the remaining primary endpoint analysis of the study
Longer follow-up data for the TEVIMBRA + ZIIHERA and chemotherapy regimen, demonstrating an improved OS hazard ratio, continued durable outcomes, and a manageable safety profile
These results reinforce findings from IA1, in which the regimen met the progression-free survival (PFS) and OS endpoints, with the overall survival benefit observed across PD-L1 and HER2+ expression levels
On August 25 2026, the US FDA approved both ZIIHERA and TEVIMBRA in combination with chemotherapy for the first-line treatment of adult patients with unresectable locally advanced or metastatic HER2+ gastric, gastroesophageal junction, or esophageal adenocarcinoma
Represents the first immunotherapy-based regimen in this setting to achieve >2 years median OS, regardless of PD-L1 status
Upcoming milestone: Results from IA2 have been submitted for presentation at a major medical meeting in the Q4'26
ORPATHYS + TAGRISSO® demonstrated significant PFS benefit with early OS signal in first-line EGFRm NSCLC with MET overexpression (Ref)
HUTCHMED announced positive Phase 3 results from the SANOVO trial in China, showing that the combination of ORPATHYS® (savolitinib; MET TKI) and TAGRISSO® (osimertinib; EGFR-TKI) significantly improved progression-free survival in treatment-naïve patients with EGFR-mutated, MET-overexpressing NSCLC
Combination demonstrated a statistically significant and clinically meaningful improvement in PFS vs TAGRISSO® alone in both the high MET and intention-to-treat (“ITT”) patient populations
In both patient populations, the combination also demonstrated OS benefit (secondary endpoint). Follow-up is ongoing
Safety profile aligned with known data; no new signals observed
Detailed results will be presented at an upcoming medical meeting and shared with regulators to support first-line approval in China
Karyopharm files sNDA for selinexor + ruxolitinib in myelofibrosis under FDA Accelerated Approval pathway (Ref)
Karyopharm announced the submission of a supplemental New Drug Application (sNDA) to the US FDA seeking Accelerated Approval and Priority Review for XPOVIO® (selinexor; XPO1 inhibitor) + ruxolitinib (JAK1/2 inhibitor) in patients with myelofibrosis
Submission is based on results from the Phase 3 SENTRY trial which demonstrated rapid, deep, and durable spleen responses, a promising survival signal, and potential disease modification
The Company expects approval under the Accelerated Approval pathway would require the FDA to agree that spleen volume reduction ≥ 35% (SVR35) is a reasonably likely surrogate endpoint to predict overall survival.
Long-term overall survival data from the Phase 3 SENTRY trial will be used to verify clinical benefit and support conversion from accelerated to traditional approval
Following acceptance, the anticipated review timelines in the Q4'26
XPOVIO has Orphan Drug (FDA/EU) and Fast Track (FDA) status for myelofibrosis
US FDA granted approval for BESREMi as the first new therapy for essential thrombocythemia (Ref)
PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation announced that the US FDA has approved BESREMi® (ropeginterferon alfa-2b-njft; long-acting interferon-based therapy) for adults with essential thrombocythemia (ET), marking the first new ET therapy in nearly three decades
BESREMi has been approved for adults with ET, regardless of their genotype or disease status, including newly diagnosed patients who are naive to cytoreductive therapy
Approval is supported by Phase 3 SURPASS‑ET trial, which demonstrated durable hematologic control, superior response rates versus anagrelide, and reduced thromboembolic events
BESREMi was already FDA‑approved for polycythemia vera (PV)
US approval follows BESREMi’s recent regulatory approval in Japan and Taiwan for ET and further expands the company’s MPN portfolio
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