Onco-Summaries: Daily Oncology Updates at a Glance

20/01/2026

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• In the Ph2b KN-942 trial, Moderna and Merck's intismeran autogene + pembro showed sustained RFS benefit at 5 years of median follow-up

  
  

• Lilly's sofetabart mipitecan received the FDA Breakthrough Therapy designation for platinum-resistant ovarian cancer

  
  

• Celcuity's NDA for gedatolisib has been accepted for priority review for advanced breast cancer

  
  

• Lantern Pharma's LP-284 received the FDA orphan drug designation for soft tissue sarcomas

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In the Ph2b KN-942 trial, Moderna and Merck's intismeran autogene + pembro showed sustained RFS benefit at 5 years of median follow-up (Ref)

Moderna and Merck & Co./MSD announced 5-yr follow-up data (pre-planned analysis) from the Phase 2b KEYNOTE-942 trial of intismeran autogene (mRNA-4157; individualized neoantigen mRNA vaccine) + pembrolizumab (anti-PD-1) as an adjuvant Tx for high-risk, stage III/IV melanoma pts.

• The vaccine regimen continued to elicit sustained improvement in RFS (primary endpoint; HR=0.510; one-sided nominal p=0.0075) vs pembrolizumab mono

• Detailed results from this follow-up analysis will be presented at an upcoming medical meeting

Lilly's sofetabart mipitecan received the FDA Breakthrough Therapy designation for platinum-resistant ovarian cancer (Ref)

The US FDA granted the Breakthrough Therapy designation to Eli Lilly and Company's sofetabart mipitecan (LY4170156; FRα ADC) for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received prior bevacizumab and mirvetuximab soravtansine, if eligible.

• The FDA Breakthrough Therapy designation is based on preliminary results from a Phase 1a/b study

• Sofetabart mipitecan has advanced into the Phase 3 FRAmework-01 study as a monotherapy in patients with platinum resistant ovarian cancer (PROC), and in combination with bevacizumab in patients with platinum-sensitive ovarian cancer (PSOC)

Celcuity's NDA for gedatolisib has been accepted for priority review for advanced breast cancer (Ref)

The US FDA accepted Celcuity's NDA for gedatolisib (PI3K/AKT/mTOR (“PAM”) inhibitor) in HR+, HER2-, PIK3CA wild-type advanced breast cancer.

• The FDA granted Priority Review and assigned a PDUFA goal date of July 17, 2026

• The NDA was submitted under the FDA’s Real-Time Oncology Review program, and is based on data from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 clinical trial

Lantern Pharma's LP-284 received the FDA orphan drug designation for soft tissue sarcomas (Ref)

The US FDA granted the orphan drug designation to Lantern Pharma's LP-284 (small molecule acylfulvene) for the treatment of soft tissue sarcomas.

• This marks the third orphan designation for LP-284, following previous orphan designations in Mantle Cell Lymphoma and High-Grade B-Cell Lymphoma with MYC and BCL2 rearrangements

• Panna Sharma, CEO, Lantern Pharma: "Receiving orphan drug designation for LP-284 in soft tissue sarcomas expands this molecule’s potential beyond hematologic malignancies into solid tumors. Adult soft tissue sarcomas are a compelling opportunity for LP-284. Unlike pediatric sarcomas driven by specific gene fusions, adult sarcomas commonly exhibit complex genomic alterations, chromosomal instability, and DNA damage response deficiencies – including BRCA-ness and homologous recombination repair defects – that align with LP-284's synthetic lethal mechanism. With over 79% of cases occurring in adults, this designation addresses a distinct patient population with significant unmet need. Our RADR® AI platform identified these DNA repair vulnerabilities, demonstrating its ability to uncover biomarker-driven precision oncology opportunities in rare cancers with limited treatment options."