October 2025


Issue No. 20

Cornerstone’s Network Connection will foster communication across our network and keep members up-to-date on the latest clinical happenings relevant to community oncology as well as Cornerstone events. 

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CORNERSTONE HAPPENINGS

We’re excited to welcome Sherif Ibrahim, PhD, to Cornerstone Specialty Network as our new Director of Clinical Operations, directly reporting to our Chief Medical Officer, Dr. Edith A. Perez. Sherif brings 10+ years of experience in clinical development and operations, including the design, planning, and execution of clinical trials. With his extensive and diverse experience across major pharmaceutical companies, Sherif will be a valuable asset to drive our clinical operations goals as we continue to build and maintain partnerships that support community practices in delivering high-quality, value-based care.

CSN Business of Oncology was held virtually on October 9th 2025 and offered an insightful exploration of the evolving landscape of community oncology. This meeting delved into the challenges and opportunities shaping community oncology practices, providing actionable strategies to thrive in a rapidly changing environment. Below is a sample of slides from the session "Comprehensive Molecular Profiling: Targeting EGFR and HER2 in Solid Tumors," Click here

 
 

CLINICAL INVESTIGATION

We are pleased to share that our efforts toward advancing real-world oncology research continue to progress. As of October 10th, 2025 enrollment in our initial clinical investigation study, Prospective Observational Study on Infusion-Related Reactions with Docivyx® or Docetaxel in Participants with Solid Malignancies [Protocol CSNAVX1] sponsored by Avyxa has reached 51 patients across all 6 participating practices. Halfway there - keep up the good work!

  • Ironwood (15 patients)
  • Northwest Cancer Centers (12 patients)
  • Cancer Center of Kansas (11 patients) 
  • Highlands Oncology Group (8 patients)
  • Zangmeister (5 patients)
  • Astera (0 patients)

Our second clinical investigation study Retrospective Observational Study on HR+ and HER2-Low (IHC 1+ or 2+ with ISH negative) and HER2-Ultralow (IHC0 with membrane staining) Metastatic Breast Cancer [Protocol CSNDSI01] sponsored by DSI is underway with 8 active sites and 33 patients enrolled!

  • Toledo Clinic Cancer Centers (19 patients)
  • Zangmeister (7 patients)
  • Cancer Center of Kansas (5 patients)
  • Premier Hematology and Oncology (2 patients)

As a quick reminder, this study is a retrospective study chart review and has been deemed to be IRB exempt by the Central IRB. Thanks to all who have already committed to this initiative, as we look forward to filling the remaining few open research site slots!


If interested in participating, please contact Sherif @ sibrahim@cornerstoneonc.com

CSN COMMUNITY ONCOLOGY INSIGHTS

CLINICAL UPDATES

FDA Updates for September 2025


On September 25, 2025, the FDA approved imlunestrant (Inluriyo, Eli Lilly and Company), an estrogen receptor antagonist, for adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy with efficacy evaluated in EMBER-3 (NCT04975308). Read More


On September 19, 2025, the FDA approved pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) for subcutaneous injection for adult and pediatric (12 years and older) solid tumor indications approved for the intravenous formulation of pembrolizumab (Keytruda, Merck) based in Study MK-3475A-D77 (NCT05722015). Read More


On September 10, 2025, the FDA approved selumetinib (KOSELUGO, AstraZeneca Pharmaceuticals LP) granules and capsules for pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). Read More


On September 9, 2025, the FDA approved gemcitabine intravesical system (Inlexzo, Janssen Biotech, Inc.) for adults with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. Gemcitabine intravesical system is co-packaged with a urinary catheter and stylet used for insertion through the urinary catheter into the bladder based on Cohort 2 of SunRISe-1 (NCT04640623). Read More

2025 UPCOMING EVENTS

The Cornerstone Specialty Network National Summit Fall 2025 scheduled for October 24 - 25, 2025 at the Fontainebleau Las Vegas, NV is fast approaching!  The 2-day live event will provide an opportunity to discuss initiatives that can improve the viability of community oncology, enable interactions with strategic pharma industry partners, and support peer-to-peer exchange for both community oncologists and advanced practice physicians. We are looking forward to a productive weekend in Las Vegas!


Be on the lookout for our Spring Summit sign-up to be held in Scottsdale, AZ in 2026!

Our next Community Oncology Fellowship Advancement Initiative (COFAI) program, "Strengthening Community Oncology Through Research," will be held live at the Fall Summit on October 25th, 2025. Keynote speakers Dr. Shruti Singh and Dr. Solly Chedid will share insights on optimizing research practices in community oncology, followed by opportunities to get involved with Cornerstone Clinical Investigations.

We will round out the year with our ESMO Data Review on December 4th, 2025 co-chaired by our own Dr. Edith A. Perez with Dr. Sujith Kalmadi and Dr. Eric S. Schaefer! Click below to join the waitlist.

Thank You

Cornerstone would like to take this opportunity to thank our select pharma partners for their support of our programs enabling us to provide unique opportunities to connect with our network, deliver key educational programs, and ultimately benefit patient care. 

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Independent Network in Community Oncology.

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Cornerstone Specialty Network LLC  •  P.O. Box 173, New Hope, PA


www.cornerstoneoncology.com