Onco-Summaries: Daily Oncology Updates at a Glance
Updated: 5 days ago
01/10/2026
Cullinan Initiates NDA Submission for Zipalertinib + Chemotherapy in 1L EGFR Exon 20ins NSCLC (Ref)
Cullinan Therapeutics announced the initiation of a US FDA New Drug Application (NDA) submission under the FDA's Real-Time Oncology Review (RTOR) program for zipalertinib (EGFR-TKI) in combination with platinum-based chemotherapy as a first-line treatment for patients with locally advanced or metastatic EGFR exon 20 insertion (ex20ins) NSCLC.
The submission is supported by results from the Phase 3 REZILIENT3 trial, which met its primary endpoint and demonstrated a statistically significant and clinically meaningful improvement in progression-free survival versus chemotherapy alone
Cullinan expects to complete the NDA submission by the end of 2026
Zipalertinib previously received FDA Breakthrough Therapy Designation for previously treated EGFR ex20ins NSCLC after platinum-based chemotherapy
A separate NDA for zipalertinib monotherapy in the post-platinum setting remains under FDA review, with a PDUFA action date of February 27, 2027
Trethera receives FDA Fast Track Designation for TRE-515 combination strategy in KRAS G12C-Mutant NSCLC (Ref)
Trethera Corporation announced that the US FDA has granted Fast Track designation to TRE-515 (dCK inhibitor) in combination with KRAS G12C inhibitors for the treatment of previously treated KRAS G12C-mutant NSCLC
Fast Track designation is applicable to patients with KRAS G12C-mutant NSCLC who have previously received both platinum-based chemotherapy and anti-PD-(L)1 therapy
Preclinical data showed continued dCK activity after KRAS inhibitor treatment, while addition of TRE-515 fully suppressed tumor dCK activity, providing biological rationale for the combination strategy
TRE-515 has demonstrated a favorable safety profile and preliminary antitumor activity in ongoing clinical evaluation
Replimune announces US launch of TUDRIQEV™ for advanced Melanoma (Ref)
Replimune announced the US commercial launch of TUDRIQEV™ (vusolimogene oderparepvec-wtpg; genetically modified HSV-1 oncolytic immunotherapy), following its FDA accelerated approval in combination with nivolumab for patients with unresectable advanced cutaneous melanoma whose disease has progressed after prior PD-1 inhibitor-based treatment
The approval is based on data from the IGNYTE trial, which demonstrated an objective response rate (ORR) of 24.2% and a median duration of response (DoR) of 14.1 months in efficacy-evaluable patients with anti-PD-1–refractory melanoma
TUDRIQEV is administered every two weeks for eight doses, with nivolumab initiated at Week 3
Continued FDA approval is contingent upon verification of clinical benefit in the ongoing Phase 3 IGNYTE-3 confirmatory study
Replimune has also launched the ReplimuneConnect Plus patient support program to assist with access, reimbursement, co-pay support, and patient navigation services
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