NCCN Adds Pemivibart for COVID-19 Prevention in B-Cell Lymphomas

As warmer weather descends upon the northern region, experts warn of a potential spike in COVID-19 cases in parallel with previous trends and research, but one subgroup of patients remains particularly vulnerable: immunocompromised patients with blood cancers.¹

COVID-19 remains a significant threat for immunocompromised patients despite waning infection rates. Vaccination alone may not be enough to protect these patients from severe COVID-19, exacerbating their preexisting conditions.

Why NCCN Added Pemivibart to Its COVID-19 Prevention Guidelines

Patients receiving B-cell-depleting therapies, anti-CD20 monoclonal antibodies, CAR T-cell therapy, or stem cell transplantation often have impaired humoral immune responses that limit vaccine effectiveness. As a result, they remain at elevated risk for severe COVID-19, hospitalization, and interruptions to cancer treatment even after completing recommended vaccination schedules. This unmet need has prompted growing interest in additional preventive strategies such as monoclonal antibody pre-exposure prophylaxis.

Pemivibart (Pemgarda; Invivyd), a recombinant human monoclonal antibody, was recently added to the National Comprehensive Cancer Network (NCCN) clinical practice guidelines in oncology for B-cell lymphomas, mimicking the Infectious Diseases Society of America (IDSA), which updated its COVID-19 guidelines in August 2024 to recommend pemivibart for the use of pre-exposure prophylaxis (PrEP) in immunocompromised patients aged 12 and older. This patient population is at a higher risk for severe progression of COVID-19.²

“This recognition reflects the growing confidence in the therapeutic potential of PEMGARDA and reinforces our commitment to immunocompromised patients, including those facing difficult-to-treat lymphomas, particularly as COVID-19 remains a year-round threat, with another surge expected this summer,” Time Lee, chief commercial officer at Invivyd, said in a press release.²

CANOPY Trial Supports Expanded Protection for Immunocompromised Patients

The NCCN’s recent recommendation addressed an unmet need in patients with B-cell lymphomas based on data from the phase 3 CANOPY trial (NCT06039449). The trial showed pemivibart to be efficacious and well-tolerated in certain immunocompromised patients, reducing the composite incidence of COVID-19 through 12 months.³

“The inclusion of PEMGARDA in the NCCN Guidelines is an important development, providing clinicians with a valuable tool to guide treatment decisions,” George Yaghmour, MD, a hematology and bone marrow specialist at Keck Medicine, University of Southern California, said in a press release. “It helps protect vulnerable patients from COVID-19, allowing them to stay out of the hospital, continue their cancer care, and focus on their recovery.”

More specifically, a subset of patients with chronic lymphocytic leukemia, assessed during the phase 3 CANOPY trial, demonstrated favorable tolerance and efficacy, providing additional evidence supporting its position as a progressive PrEP option for COVID amongst the growing treatment landscape.⁴

“Strategies to protect [immunocompromised patients] further include pre-exposure prophylaxis platform deployment, which, in the form of pemivibart, we want every 3 months,” Muhammad Bilal Abid, MD, a clinician scientist at the University of Texas Health Science Center, said in an interview with The American Journal of Managed Care^®. “And now, just about now, we have an approval for ensitrelivir (Xocova; Shionogi) to be used for postexposure prophylaxis for COVID-19 among high-risk exposures.”

Beyond preventing infection, experts emphasize that reducing COVID-19 risk can help patients maintain continuity of cancer care. COVID-19 infections have previously contributed to delays in chemotherapy, radiation therapy, stem cell transplantation, and other time-sensitive treatments. For patients with hematologic malignancies, avoiding treatment interruptions may be just as important as preventing hospitalization, making effective prophylactic strategies increasingly relevant for oncology practices and managed care organizations.

References

1. McCrear S. COVID-19 may follow a different seasonal pattern than influenza, RSV. AJMC^®. June 29, 2026. Accessed June 30, 2026. https://www.ajmc.com/view/covid-19-may-follow-a-different-seasonal-pattern-than-influenza-rsv

2. Invivyd announces inclusion of PEMGARDA® (pemivibart) in National Comprehensive Cancer Network® (NCCN®) clinical practice guidelines in oncology for B-cell lymphomas. Invivyd, Inc. May 23, 2026. Accessed June 30, 2026. https://investors.invivyd.com/news-releases/news-release-details/invivyd-announces-inclusion-pemgardar-pemivibart-national/

3. Wolfe CR, Cohen J, Mahoney K, et al. Safety and efficacy of pemivibart, a long-acting monoclonal antibody, for prevention of symptomatic COVID-19: interim results from a phase 3 randomized clinical trial (CANOPY). Clin Infect Dis. Published online May 24, 2025. doi:10.1093/cid/ciaf265

4. McCrear S. Pemivibart shows safety, prevents COVID-19 in CLL subset in phase 3 CANOPY trial. AJMC. April 8, 2026. Accessed June 30, 2026. https://www.ajmc.com/view/pemivibart-shows-safety-prevents-covid-19-in-cll-subset-in-phase-3-canopy-trial