ASCO Selects PALLAS Trial Update for October 18 Plenary

The global phase 3 trial called PALLAS (PALbociclib CoLlaborative Adjuvant Study) involved PrECOG, LLC, and evaluated standard adjuvant endocrine therapy with or without palbociclib for women with early breast cancer. In May 2020, an interim analysis showed that the study was unlikely to meet its primary endpoint. During the October ASCO Plenary Series, PrECOG’s Angela DeMichele, MD, MSCE (University of Pennsylvania), global PALLAS co-chair, will deliver the results of a preplanned analysis of the cohort of patients diagnosed with stage 2A disease.

Mark your calendar for the virtual session on Tuesday, October 18, 2022, from 3:00 PM – 4:00 PM ET. No registration is required to participate, but you must log in with an ASCO.org username and password to access the broadcast session. Learn more or add the session to your calendar now.

The PALLAS trial is and will continue to be one of the most successful worldwide collaborations among academic study groups. PALLAS is co-sponsored by the Austrian Breast & Colorectal Cancer Study Group (ABCSG) and Alliance Foundation Trials (AFT) as part of a clinical research collaboration with Pfizer and other study groups, including NSABP Foundation Inc; PrECOG, and the Breast International Group (BIG). Mandatory tissue block collection from the outset of the enterprise, along with serially collected blood samples, provides an enormous treasure of opportunities for researchers worldwide to interrogate mechanisms of disease through the Trans-PALLAS biomarker discovery program.

Jedd Wolchok Leads Weill Cornell Cancer Center

Jedd D. Wolchok, MD, PhD, is the Meyer Director of the Sandra and Edward Meyer Cancer Center at Weill Cornell Medicine, effective September 12. In this role, Dr. Wolchok leads an expansive multidisciplinary research and clinical enterprise. The Center is dedicated to translating groundbreaking discoveries on the underlying causes of cancer into cutting-edge treatment approaches and personalized therapies to improve patient outcomes. He joins the Meyer Cancer Center after more than 25 years at Memorial Sloan Kettering Cancer Center, where he served most recently as chief of the Immuno-Oncology Service.

A longtime member of ECOG-ACRIN Cancer Research Group (ECOG-ACRIN), Dr. Wolchok is currently chair of the Melanoma Committee. He is a clinician-scientist whose research focuses on exploring innovative immunotherapeutic strategies, with an emphasis on melanoma research and clinical expertise in the care of people with advanced stages of the disease. He was instrumental in the clinical development leading to the approval of ipilimumab for advanced melanoma. Learn more.

NCI Honors Augusto Ochoa

The National Cancer Institute (NCI) honored Augusto Ochoa, MD (LSU Health New Orleans/LSU Health-LCMC Cancer Center) as the 2022 recipient of the Harry Hynes Award for Outstanding Contributions to Clinical Trials and Community Research. Dr. Ochoa serves on the ECOG-ACRIN Principal Investigator Committee as PI for the Gulf South Minority Underserved (MU) NCORP. Gulf South MU NCORP is the only statewide cancer clinical trials program in Louisiana, which Dr. Ochoa began building in 2014.

The recognition is NCI’s most prestigious award honoring excellence in community-based cancer research. NCI presented the award to Dr. Ochoa during the NCORP Annual Meeting in late August. Learn more.

ECOG-ACRIN Investigators Advance at NYU

Over the summer, NYU Langone Health’s Perlmutter Cancer Center appointed several ECOG-ACRIN researchers to leadership positions: Kristen Spencer, DO (left), chair of ECOG-ACRIN’s Genomics Subcommittee and member of the Task Force on Advancement for Women, was named director of Perlmutter’s Phase 1 Developmental Therapeutics Program. Janice Mehnert, MD (middle), co-chair of the ECOG-ACRIN Melanoma Committee, became site principal investigator (PI) for the NCI–Cancer Therapy Evaluation Program (CTEP) Experimental Therapeutics Clinical Trials Network, which Perlmutter joined in July. Both Dr. Mehnert and Catherine S. Diefenbach, MD (right), the voting member of the ECOG-ACRIN Principal Investigator Committee, serve as national PIs for CTEP protocols. Learn more.

TMIST Passes 76,000 Enrollments

The study chair for this trial is Etta Pisano, MD (American College of Radiology Chief Research Officer).

The TMIST breast cancer screening trial continues to grow at a steady pace, with total accrual of 76,580 participants among 124 active sites as of October 13, 2022. The success of the trial is impressive in light of a recent nationwide analysis showing that screening mammography volumes have yet to rebound to pre-pandemic levels (Lars J. J Am Coll Radiol. June 2022).

Important reminders:

• Share the TMIST advocacy blog trial spotlight with cancer research advocates and others in your community
• Access education and recruitment materials in multiple languages (English, Spanish, Chinese Simplified, Korean, and Vietnamese)
• Tell other sites about this trial! Interested personnel may visit acr.org/TMIST, read this card, and watch this video. In addition, personnel may contact TMIST staff to discuss the study requirements, reimbursement/payment structure, and the application process.
• Consider the supplemental EAQ201 trial assessing COVID-19-related financial hardship and distress in women who decline participation in TMIST

MDS Resource Request Portal Now Available

The National Myelodysplastic Syndromes (MDS) Natural History Study (also known as NHLBI-MDS) has launched a new, web-based portal and invites researchers to request access to a rich clinical dataset, digital H&E slides, and genetic sequencing data collected prospectively from a large cohort of MDS patients enrolled across the US. Resources continue to be added to the database and biorepository as new patients join NHLBI-MDS and the existing cohort is followed longitudinally. The portal is an exciting opportunity for scientists to pursue cutting-edge research that will contribute to our understanding of MDS and improve diagnostic and treatment options. Learn more.

New Integrated Diagnostics Grant Program

Attention data scientists, physicists, and other radiology research personnel: A new grant program will soon be available to support integrated diagnostics research. Among the initiatives eligible for support are those that utilize the various datasets amassed through ECOG-ACRIN clinical trials (demographics, pathology, genetics, treatments, images, and outcomes, for example) to ask questions, develop artificial intelligence (AI) algorithms, and build models that create new knowledge. NCI-MATCH and TMIST are examples of datasets that could be used to advance the field. 

Please attend the Fall 2022 Group Meeting in Washington, DC, where Etta D. Pisano, MD, and fellow imaging leaders will discuss the new program. Register to attend one of these sessions – either in person or remotely:

• Imaging Committee

Wednesday, October 26, from 10:30 AM – 12:00 PM ET

• Prevention, Screening, and Surveillance Committee

Thursday, October 27, from 12:00 PM – 2:00 PM ET

Registration is required via the Group Meeting website.

Monkeypox Vaccine, TPOXX, and Clinical Trials

The NCI recently issued guidance for administering the Jynneos Monkeypox Vaccine and the antiviral drug tecovirimat (TPOXX). The guidance applies to participants in studies being conducted under an investigational new drug (IND) application held by the Cancer Therapy Evaluation Program (CTEP).

For the Jynneos Monkeypox Vaccine, the highlights are:

• This vaccine is not considered a live virus vaccine in terms of eligibility or administration in CTEP IND clinical trials; eligibility criteria excluding participants who have received a live virus vaccine do not apply to participants who have received this vaccine
• Use of this vaccine is per investigator discretion, but CTEP recommends that all high-risk study participants maintain awareness and be vaccinated, unless otherwise contraindicated
• Whenever possible, follow the below guidelines for scheduling administration of the vaccine:
  • In participants who have not yet started treatment, the vaccine should be administered at least 3 days prior to start of treatment
  • In participants who are receiving study infusion therapy, the vaccine should not be administered on an infusion day; where possible, the vaccine should be administered during an off week, or at least a week apart from an infusion day
  • In patients who are receiving daily oral therapy, the vaccine should not be administered within a week of any dose modification
  • In patients with an arm that has undergone lymphadenectomy, the vaccine should be administered in the opposite arm
  • Administration of the vaccine should be documented as a concomitant medication, except in trials for which concomitant medications are not collected
• The full guidance document is available at ctsu.org

For TPOXX, please see the CDC’s Information on Obtaining and Using TPOXX.