Onco-Summaries: Daily Oncology Updates at a Glance

18/08/2026

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• BH-30643 earns US FDA Fast Track designation for pretreated NSCLC

• FDA Endorses Registrational Path for Pelareorep in RAS‑Mutant MSS Colorectal Cancer

• PLN-101095 Secures US FDA Fast Track for ICI-Refractory Solid Tumors

• US FDA Grants Fast Track to ETX‑19477, a Novel PARG Inhibitor for BRCA‑Mutated Breast Cancer

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BH-30643 earns US FDA Fast Track designation for pretreated NSCLC (Ref)

BlossomHill Therapeutics announced that its investigational drug BH-30643, a macrocyclic OMNI-EGFR™ inhibitor, has received US FDA Fast Track designation for the treatment of advanced or metastatic EGFR C797S-positive NSCLC following prior third-generation EGFR TKI therapy

BH-30643 is being evaluated in the SOLARA Phase 1/2 global trial, spanning 40+ sites across 10 countries, with expansion cohorts for both TKI-pretreated and TKI-naïve patients

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FDA Endorses Registrational Path for Pelareorep in RAS‑Mutant MSS Colorectal Cancer (Ref)

Oncolytics Biotech announced that it has reached alignment with the FDA on the registrational path for pelareorep (dsRNA oncolytic immunotherapy) in second-line RAS-mutant, MSS metastatic colorectal cancer.

The agency’s written feedback supports advancing the ongoing REO 033 trial into a pivotal Part B expansion, with accelerated approval based on objective response rate and duration of response, and progression-free survival supporting full approval

The FDA recommended moving directly to an End-of-Phase meeting to finalize the pivotal design

• Trial Design:

  
  

  • Part A: Randomized study of pelareorep + FOLFIRI + bevacizumab vs. FOLFIRI + bevacizumab alone (n=60)

  
  

  • Part B: Planned pivotal expansion, minimizing transition time after Part A readout

Pelareorep holds Fast Track designation for colorectal and other GI cancers

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PLN-101095 Secures US FDA Fast Track for ICI-Refractory Solid Tumors (Ref)

Pliant Therapeutics has received US FDA Fast Track designation for its investigational therapy PLN-101095, an oral dual-selective inhibitor of αvβ8 and αvβ1 integrins, when used in combination with pembrolizumab for the treatment of immune checkpoint inhibitor (ICI)-refractory solid tumors

PLN-101095 is currently being evaluated in the Phase 1a/1b FORTIFY trial (NCT06270706), with data anticipated in 2027

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US FDA Grants Fast Track to ETX‑19477, a Novel PARG Inhibitor for BRCA‑Mutated Breast Cancer (Ref)

858 Therapeutics announced that ETX‑19477 (PARG inhibitor) has been granted US FDA Fast Track designation for the treatment of patients with BRCA‑mutated, HR+/HER2‑ unresectable or metastatic breast cancer

ETX‑19477 is being evaluated in an ongoing Phase 1/2 trial across advanced solid tumors, with Phase 2 monotherapy cohorts enrolling BRCA‑mutated ovarian and breast cancer patients

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