Yu Fujiwara, MD, from Mount Sinai Beth Israel in New York City, and colleagues conducted a systematic review and meta-analysis to examine how adding an immune checkpoint blockade to perioperative therapy affects treatment-related adverse events. Data were included from 28 randomized controlled trials with 16,976 cancer patients.

The researchers found no significant association for addition of an immune checkpoint blockade with increased treatment-related deaths, and this finding was consistent across immune checkpoint blockade subtypes. Across 9864 patients treated with an immune checkpoint blockade, 40 fatal toxicities were identified, with pneumonitis the most common (15.0%); among 7112 patients who were not treated with an immune checkpoint blockade, 13 fatal toxicities were identified. The incidence rates of grade 3 to 4 treatment-related adverse events, adverse events leading to treatment discontinuation, and treatment-related adverse events of any grade were increased with the addition of an immune checkpoint blockade (odds ratios, 2.73, 3.67, and 2.60, respectively). Increased incidence rates of treatment-related deaths and grade 3 to 4 adverse events were seen in association with an immune checkpoint blockade vs placebo design primarily used as adjuvant therapy (odds ratios, 4.02 and 5.31, respectively), while incidence was not increased with the addition of an immune checkpoint blockade in the neoadjuvant setting.

“Our analysis points to a need for further research into risk factors and identification of appropriate biomarkers to predict both efficacy and toxicity associated with cancer immunotherapy,” Fujiwara said in a statement.

Several authors disclosed ties to the biopharmaceutical industry.

Abstract/Full Text (subscription or payment may be required)

Editorial (subscription or payment may be required)

The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for avasopasem manganese (GC4419) for radiotherapy (RT)-induced severe oral mucositis (SOM) in patients with head and neck cancer undergoing standard of care treatment.

Avasopasem is a selective dismutase mimetic designed to convert superoxide to hydrogen peroxide, thereby stopping the cascade that results in radiation damage to normal tissue. The NDA is supported by the randomized, double-blind, placebo-controlled phase 3 ROMAN trial (ClinicalTrials.gov Identifier: NCT03689712) and the phase 2b GT-201 (ClinicalTrials.gov Identifier: NCT02508389) trial. These studies enrolled a total of 678 patients with locally advanced, nonmetastatic squamous cell carcinoma of the head and neck. 

In the ROMAN trial (N=455), results showed that treatment with avasopasem met the primary endpoint demonstrating a statistically significant 16% relative reduction in the incidence of SOM (54% vs 64%; P =.045) and a 56% relative reduction in the duration of SOM (median, 8 vs 18 days; P =.002) compared with placebo. There were also improvements observed across multiple secondary and exploratory endpoints, including the incidence and duration of grade 4 incidence of SOM.

An analysis at 1 year showed that avasopasem did not affect the treatment benefit of standard of care chemoradiotherapy. Tumor outcomes and overall survival were observed to be similar in the avasopasem and placebo arms.

In the GT-201 trial, treatment with avasopasem statistically significantly reduced the duration of SOM compared with placebo (median, 1.5 days vs 19 days; P =.024). Avasopasem was also associated with a lower incidence of SOM (43% vs 65%; P =.009) and grade 4 SOM (16% vs 30%; P =.045) compared with placebo.

“The impact of SOM, the most burdensome toxicity of standard-of-care RT, on a patient’s physical and psychological wellbeing is substantial, particularly when hospitalization and surgical placement of feeding tubes to maintain nutrition and hydration are required,” said Mel Sorensen, MD, President and Chief Executive Officer of Galera Therapeutics. “In some patients, SOM is so debilitating that they may delay and/or discontinue potentially curative RT, undermining their care. Avasopasem, if approved, has the potential to reduce pain and suffering for these patients, as well as reduce the costs associated with hospitalizations, surgical placement of feeding tubes, and other treatment burdens.”

A Prescription Drug User Fee Act target date of August 9, 2023 has been set for the application. 

References

1. Galera announces FDA acceptance and Priority Review of avasopasem NDA for radiotherapy-induced severe oral mucositis. News release. Galera Therapeutics, Inc. Accessed February 15, 2023. https://www.globenewswire.com/news-release/2023/02/15/2608650/0/en/Galera-Announces-FDA-Acceptance-and-Priority-Review-of-Avasopasem-NDA-for-Radiotherapy-Induced-Severe-Oral-Mucositis.html.
2. Anderson CM, Lee CM, Saunders DP, et al. Phase IIb, randomized, double-blind trial of GC4419 versus placebo to reduce severe oral mucositis due to concurrent radiotherapy and cisplatin for head and neck cancer. J Clin Oncol. 2019;37(34):3256-3265. Published online October 16, 2019. doi:10.1200/JCO.19.01507
3. Anderson CM, Lee CM, Kelley Jr, et al. ROMAN: phase 3 trial of avasopasem manganese (GC4419) for severe oral mucositis (SOM) in patients receiving chemoradiotherapy (CRT) for locally advanced, nonmetastatic head and neck cancer (LAHNC). J Clin Oncol. 2022;40 (suppl 16):abstr 6005. Published online June 2, 2022. doi:10.1200/JCO.2022.40.16_suppl.6005

Avzivi is a vascular endothelial growth factor inhibitor indicated for the treatment of:

• Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment.
• Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen.
• Unresectable, locally advanced, recurrent or metastatic nonsquamous non-small cell lung cancer, in combination with carboplatin and paclitaxel for first-line treatment.
• Recurrent glioblastoma in adults.
• Metastatic renal cell carcinoma in combination with interferon alfa.
• Persistent, recurrent, or metastatic cervical cancer, in combination with paclitaxel and cisplatin or paclitaxel and topotecan.
• Epithelial ovarian, fallopian tube, or primary peritoneal cancer, in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for platinum-resistant recurrent disease who received no more than 2 prior chemotherapy regimens.

The approval was based on a comprehensive data package that included a pharmacokinetic study (ClinicalTrials.gov Identifier: NCT05865574) in healthy individuals, as well as a phase 3 comparative study (ClinicalTrials.gov Identifier: NCT03329911) in patients with advanced nonsquamous non-small cell lung cancer.

“The global phase 3 clinical trial has confirmed that Avzivi is highly similar to Avastin in terms of efficacy, safety and immunogenicity,” said professor Li Zhang, leading investigator for global phase 3 study of Avzivi. “The approval of Avzivi by the FDA will provide lung and colorectal cancer patients a new cost-effective treatment option.”

Breakthroughs in targeted therapy and immunotherapy are partly responsible for the recent decline in cancer deaths seen in the United States, according to the AACR Cancer Progress Report 2023.¹

The overall rate of cancer death in the US fell by 33% between 1991 and 2020, which translates to 3.8 million lives saved, according to the report. Death rates have decreased for lung cancer, colorectal cancer, prostate cancer, female breast cancer, and melanoma.

“These gains have really reflected a whole variety of different advances, but mostly this has been about efforts in basic science,” AACR President Philip D. Greenberg, MD, of Fred Hutchinson Cancer Research Center in Seattle, said during a presentation about the AACR report.

Dr Greenberg noted that initiatives such as the Human Genome Project and The Cancer Genome Atlas have enabled the creation of targeted therapies, which are “increasingly precise and decreasingly toxic.”

Immunotherapy breakthroughs have also reduced the toxicity of treatments, leading to improved quality of life for patients. “Precision oncology, personalized medicine; it’s about creating drugs and using them to very selectively target the disease and not injure the person,” Dr Greenberg summarized.

The AACR report highlighted several targeted therapies with unique mechanisms of action that have been approved by the US Food and Drug Administration (FDA) since the early 2000s, including gefitinib in 2003, crizotinib in 2011, and sotorasib in 2021.

All of these therapies were approved to treat lung cancer, and these approvals coincided with declining lung cancer deaths. The decrease in lung cancer deaths per year grew from 0.9% between 1995 and 2005 to nearly 5% between 2014 and 2020.

The report also highlighted more recent FDA approvals. Between August 1, 2022, and July 31, 2023, the FDA approved 14 new cancer therapies and expanded the approved use of 12 therapies to encompass new cancers. The therapies include a range of cell-signaling inhibitors, antibody-drug conjugates, bispecific antibodies, and immune checkpoint inhibitors.

“A decade ago, there was 1 single immune checkpoint inhibitor,” Dr Greenberg pointed out. “Now . . . 11 checkpoint inhibitors have now been approved by the FDA up through 2023. And rather than using it to treat the single disease that it was approved for a decade ago, we now use it to treat 20 diseases.”

Two new imaging agents — pafolacianine and flotufolastat fluorine-18 —were also approved by the FDA between August 1, 2022, and July 31, 2023.

Ongoing Challenges

“Of course, despite all this progress, there’s a whole lot of work that needs to be done,” Dr Greenberg said. “There are still, even now, structural barriers for lots of people. There’s clearly disproportionate medical care being delivered to medically underserved populations. This includes, of course, racial and ethnic minorities, but it also includes the rural populations, which is not commonly appreciated, but rural populations participate very minimally in cancer trials.”

“Similarly, although precision medicine has really improved outcomes, we need ways of expanding that so that it includes more diseases,” Dr Greenberg added. “Pancreatic cancer, for example, and glioblastoma still have horrible 5-year relative survival rates, and so we need new advances.”

To address some of these challenges, the AACR has launched a new initiative known as the AACR Cancer Centers Alliance.²  The initiative aims to encourage collaboration among US cancer centers and “accelerate the pace of discovery by providing an ongoing mechanism for transferring new knowledge, sharing resources . . ., and driving innovation that impacts cancer science, cancer care delivery, and science and health policy.”²

Dr Greenberg suggested that the future of cancer research is bright. “I really enthusiastically look forward to what can happen,” he said. “I think there’s no reason not to be optimistic. . . . We’re in this time of unparalleled opportunities.”

Disclosures: Dr Greenberg has relationships with Affini-T, Rapt Therapeutics, Elpiscience, Fibrogen, Immunoscape, Metagenomi, Earli, Catalio, and Nextech. No disclosures were provided in relation to the AACR Cancer Progress Report 2023. Some authors of the Cancer Discovery article declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the article for a full list of disclosures.

Cancer patients were more likely to die from the BA.1 and BA.2 omicron variants of SARS-CoV-2 than from wild-type SARS-CoV-2, according to research published in JAMA Oncology.^1,2

The study showed that, among US cancer patients, COVID-19 deaths were more likely during the initial omicron wave when the BA.1 and BA.2 variants were in circulation (December 2021 to February 2022) than when wild-type SARS-CoV-2 was circulating (December 2020 to February 2021).

According to data from the US Centers for Disease Control and Prevention, there were 54,692 COVID-19 deaths among patients with cancer and 1,008,510 COVID-19 deaths in the general population from March 1, 2020, through May 31, 2022.

This study included 34,350 patients with cancer and 628,156 individuals from the general population who died from COVID-19 when wild-type SARS-CoV-2 was in circulation (December 2020-February 2021), the delta variant was in circulation (July 2021-November 2021), or the BA.1 and BA.2 omicron variants were in circulation (December 2021-February 2022).

The highest number of COVID-19-related deaths among patients with cancer occurred during the 2021-2022 omicron wave. At the peak of this wave, in January 2022, there were 18% more deaths than during the peak of the wild-type period, which occurred during January 2021.

This trend was maintained when patients were stratified by age group. The number of deaths per month among patients with cancer younger than 50 years of age was 64% higher during the 2021 to 2022 omicron wave than during the wild-type wave. The number was 62% higher among patients aged 50 to 59 years, 31% higher for those aged 60 to 69 years, and 16% higher for those aged 70 to 79 years.

When the researchers looked at individual cancer types, they found that COVID-19 deaths were more likely during the 2021-2022 omicron wave for most cancer types. The exceptions were brain cancer (mortality ratio [MR], 0.77; 95% CI, 0.65-0.90), thyroid cancer (MR, 0.76; 95% CI, 0.54-0.99), and bladder cancer (MR, 0.58; 95% CI, 0.52-0.65).

Patients with lymphoma had the greatest increase in deaths from the wild-type wave to the 2021 to 2022 omicron wave, at 38% (mortality ratio [MR], 1.38; 95% CI, 1.31-1.45).

In the general population, the highest number of COVID-19 deaths per month occurred when wild-type SARS-CoV-2 was prevalent. At the peak of the initial omicron wave in January 2022, there were 21% fewer deaths in the general US population than at the peak of the wild-type period in January 2021 (MR, 0.69; 95% CI, 0.69-0.70).

“[W]hile the general US population experienced a large reduction in COVID-19 mortality during the winter Omicron period, patients with cancer experienced the highest COVID-19 mortality during the winter Omicron period, likely due to increased SARS-CoV-2 exposure during this period combined with the reduced effectiveness of COVID-19 vaccines and increased risk of COVID-19 mortality in this population,” the researchers wrote. “With future COVID-19 waves imminent, strategies to protect those at highest risk should remain a high priority, even during future pandemic waves with less virulent SARS-CoV-2 variants.”

Disclosures: One of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

References

1. Potter AL, Vaddaraju V, Venkateswaran S, et al. Deaths due to COVID-19 in patients with cancer during different waves of the pandemic in the US. JAMA Oncol. Published online August 31, 2023. doi: 10.1001/jamaoncol.2023.3066

2. SARS-CoV-2 sequences by variant, United States, Jan 3, 2022. Our World in Data. Updated August 22, 2023. Accessed September 1, 2023.

HealthDay News — Chimeric antigen receptor (CAR)-expressing T cells that target the disialoganglioside GD2 expressed on tumor cells (GD2-CAR T cells) are feasible and safe for children with heavily pretreated neuroblastoma, according to a study published in the April 6 issue of the New England Journal of Medicine.

Francesca Del Bufalo, MD, from IRCCS Ospedale Pediatrico Bambino Gesù in Rome, and colleagues conducted a phase 1/2 clinical trial involving 27 children with heavily pretreated neuroblastoma (12 with refractory disease, 14 with relapsed disease, and one with a complete response at the end of first-line therapy) who received GD2-CAR T cells expressing the inducible caspase 9 suicide gene (GD2-CART01).

The researchers observed no failure to generate GD2-CART01. In the phase 1 part of the trial, three dose levels were tested (3-, 6-, and 10×10⁶ CAR-positive T cells/kg body weight), with no dose-limiting toxic effects reported. For the phase 2 part of the trial, the recommended dose was 10×10⁶ CAR-positive T cells/kg. In 74% of patients, cytokine release syndrome occurred and was mild in all but one patient. The suicide gene was activated in one patient, with rapid elimination of GD2-CART01. GD2-targeted CAR T cells expanded in vivo; up to 30 months after infusion, they were detectable in peripheral blood in 26 of 27 patients. Overall response was 63 percent, with nine and eight patients having a complete and partial response, respectively. Three-year overall survival and event-free survival were 60 and 36%, respectively, among children receiving the recommended dose.

“GD2-CART01 may induce sustained eradication of disease in a proportion of patients with relapsed or refractory neuroblastoma,” the authors write.

Bellicum Pharmaceuticals donated rimiducid for the trial.

Abstract/Full Text (subscription or payment may be required)

Editorial (subscription or payment may be required)

Chemotherapy-Induced Nausea and Vomiting Prophylaxis

The cisplatin shortage that has affected cancer centers and patients across the US is nearly resolved, according to a statement from the Biden Administration.¹

The White House reported last week that the cisplatin supply has been restored to almost 100% of pre-shortage levels.

According to the US Food and Drug Administration’s (FDA) drug shortage database, 3 companies had cisplatin available on allocation as of September 18.² Additional supplies of cisplatin are expected to be released this month and next month.

The shortage of cisplatin has occurred alongside prolonged shortages of several other cancer drugs, including methotrexate and carboplatin.³ In June, the National Comprehensive Cancer Network (NCCN) published survey results reporting that cisplatin was in short supply at 70% of included cancer centers, and carboplatin was in short supply at 93%.⁴

The FDA has worked to alleviate these shortages over the past several months.¹ In June, the FDA announced that it would work with Chinese drugmaker Qilu Pharmaceutical and Canadian pharmaceutical company Apotex to temporarily import cisplatin.⁵ According to the FDA, distribution of this product has been completed.²

The FDA also worked with various drug manufacturers to increase production of cisplatin, carboplatin, and methotrexate.¹ According to the FDA database, several companies have methotrexate and carboplatin available now, and additional supplies of both drugs are expected this month and next month.²

“The Administration will continue to work through the FDA, the Department of Health and Human Services, and other agencies to address and prevent drug shortages and mitigate impacts to people facing a cancer diagnosis,” the White House said in its statement.¹

This is despite the fact that cancer survivors are more likely to be vaccinated against COVID-19 and just as likely as the general population to be infected with SARS-CoV-2. These findings were published in the Journal of the National Cancer Institute.

For this study, researchers evaluated data from the National Health Interview Survey in 2021 and 2022. The cohort from 2021 included 3428 cancer survivors and 26,023 control individuals without a cancer history. The cohort from 2022 included 3218 cancer survivors and 24,393 control individuals.

The cancer survivors were more likely than control individuals to have received 2 or more COVID-19 vaccines in 2021 (66.6% and 62.3%, respectively; P =.003) and 2022 (77.0% and 72.4%, respectively; P <.001).

However, cancer survivors were just as likely as control individuals to report having COVID-19 in 2021 (14.1% and 14.2%, respectively; P =.93) and 2022 (39.9% and 39.3%, respectively; P =.55).

Cancer survivors were more likely than control individuals to report moderate to severe COVID-19 symptoms in 2021 (62.5% and 54.2%, respectively; P =.02). In 2022, there was a trend toward more moderate and severe COVID-19 among cancer survivors, but the difference between cancer survivors and control individuals was not statistically significant (54.5% and 51.3%, respectively; P =.13).

However, the data from 2022 showed that cancer survivors were more likely than control individuals to have symptoms of long COVID (20.6% and 17.3%, respectively; P =.04). There were no data on long COVID from 2021.

“With the continuing high infectious rate and seasonal resurgences of COVID-19 infections and ongoing recommendations for vaccination, especially for vulnerable populations, monitoring the impact of COVID-19 infection and the effectiveness of prevention and control strategies continue to be a public health priority,” the researchers wrote. “Our findings suggest the need for tailored efforts to prevent and control COVID-19 infection for cancer survivors.”

A dexamethasone-free regimen controls vomiting and nausea from highly emetogenic chemotherapy more effectively than a dexamethasone-based regimen, according to trial results presented at ASCO Breakthrough 2023.

In this phase 3 trial, treatment with the dexamethasone-free regimen, olanzapine, palonosetron, and fosaprepitant (OPF), led to higher complete response (CR) rates for vomiting, nausea, and total control than the dexamethasone-based regimen, olanzapine, palonosetron, and dexamethasone (OPD).

These results suggest that it’s time to move away from using dexamethasone as an antiemetic, said study presenter Venkatraman Radhakrishnan, MD, of the Cancer Institute in Chennai, India.

“It’s taken 4 decades for us to say that dex is no longer needed as an antiemetic, and I think this is a breakthrough,” Dr Radhakrishnan said.

Dr Radhakrishnan and colleagues uncovered this finding via a phase 3 trial of cancer patients who were randomly assigned to receive OPD (n=174) or OPF (n=172). Baseline characteristics were similar between the arms.

Patients had breast cancer (63% in the OPD arm and 68% in the OPF arm), head and neck cancer (26% and 25%, respectively), lung cancer (7% and 4%), or other cancers (4% and 3%). The most frequently used chemotherapy regimen was doxorubicin and cyclophosphamide (63% and 68%, respectively), followed by platinum-based chemotherapy (37% and 30%).

The primary endpoint was CR. This was defined as no emetic episodes and no use of rescue medication during the overall observation period, which was the first 120 hours after the initial dose of chemotherapy.

In the overall period, the CR rates for vomiting, nausea, and total control were all significantly higher in the OPF arm than in the OPD arm. However, outcomes varied during the acute period (0-24 hours) and the delayed period (24-120 hours), as seen in the table below.

Toxicity outcomes were similar between the arms, Dr Radhakrishnan said. However, fatigue and drowsiness were more common in the OPF arm during the acute period. Insomnia was more common in the OPD arm in the acute and delayed periods.

Dr Radhakrishnan said these results suggest that a dexamethasone-free regimen is both viable and feasible. He highlighted that about 80% of patients had control of vomiting with the OPF regimen.

“[I]t’s time to get away from dex, based on our study,” Dr Radhakrishnan said. “We planned a non-inferiority study and ended up showing superiority” of OPF over OPD.

Drug-Induced Photosensitivity

The Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Galera Therapeutics regarding the New Drug Application for avasopasem manganese for radiotherapy-induced severe oral mucositis in patients with head and neck cancer undergoing standard of care treatment.

According to the letter, the application could not be approved in its current form as data from the phase 3 ROMAN trial (ClinicalTrials.gov Identifier: NCT03689712) and the phase 2b GT-201 (ClinicalTrials.gov Identifier: NCT02508389) trial were not sufficient to support the effectiveness of avasopasem in reducing severe oral mucositis in patients with head and neck cancer. The FDA is requiring an additional clinical trial prior to resubmission.

“This response from the FDA is deeply disappointing for Galera and for patients who suffer from severe oral mucositis,” said Mel Sorensen, MD, Galera’s President and CEO. “We continue to believe in avasopasem’s potential to bring a meaningful benefit to these patients, who currently have no FDA-approved drugs for this debilitating condition.”

Avasopasem is a selective dismutase mimetic designed to convert superoxide to hydrogen peroxide, thereby stopping the cascade that results in radiation damage to normal tissue.

Aron Onerup, MD, PhD, from the University of Gothenburg in Sweden, and colleagues examined BMI at age 18 years and incident site-specific cancer (malignant melanoma; leukemia; myeloma; Hodgkin lymphoma; non-Hodgkin lymphoma; and cancer in the lungs, head and neck, central nervous system, thyroid, esophagus, stomach, pancreas, liver and gallbladder, colon, rectum, kidney, and bladder) to estimate population attributable fractions due to BMI based on projected obesity prevalence. The analysis included 1.5 million men.

The researchers found that 78,217 men subsequently developed cancer during a mean 31 years of follow-up. There was a linear association between BMI and the risk for developing all 18 site-specific cancers assessed. In some instances, there was an association even with BMI levels usually defined as normal (20 to 25 kg/m²). For prostate cancer, there was an inverse association observed, with higher BMI associated with lower risk. Gastrointestinal cancers had the highest hazard ratios and population attributable fractions.

“If current obesity trends continue, our findings provide additional support for rapid action to stem the course of the obesity epidemic and, with a large prevalence of youth overweight and obesity already in existence, to prepare the health care system for a steeply increasing number of cancer cases,” the authors write.

Abstract/Full Text

After 3 or 4 doses, mRNA-based COVID-19 vaccines are similarly effective in reducing the risk of severe COVID-19 or hospitalization for patients with cancer and the general population, according to research published in JAMA Oncology.

During the delta wave and 2022 omicron wave, cancer patients and control patients had lower rates of severe COVID-19 and COVID-19 hospitalization if they received 3 or 4 doses of an mRNA vaccine than if they received only 2 doses.

However, there was no significant difference in the incidence of COVID-19 by vaccine dose for cancer patients or control individuals.

For this study, researchers in Singapore examined the association between COVID-19 outcomes and vaccine doses over 2 time periods: September 15, 2021, to December 20, 2021 (delta wave), and January 20, 2022, to November 11, 2022 (omicron wave).

The analysis included 73,608 cancer patients, 23,217 with active cancer and 50,391 cancer survivors, and 621,475 matched control individuals. Vaccinated patients received Pfizer-BioNTech’s BNT162b2 vaccine or Moderna’s mRNA-1273 vaccine.

The researchers noted that, during both the delta and omicron waves, the incidence rate ratios (IRRs) for COVID-19 were not significantly different by vaccine dose for cancer patients or control individuals. There were no significant differences in the incidence of COVID-19 between patients who received 0-1 vaccine dose, those who received 2 doses, and those who received 3 or 4 doses.

On the other hand, the IRRs for COVID-19 hospitalization were significantly lower for cancer patients, cancer survivors, and control patients who received 3 or 4 doses of an mRNA vaccine than for those who received 2 doses.

Similarly, the IRRs for severe COVID-19 were significantly lower for cancer patients, cancer survivors, and control patients who received 3 or 4 doses of an mRNA vaccine than for those who received 2 doses.

The researchers noted that, during the delta wave, vaccine effectiveness against severe COVID-19 or hospitalization after 2 doses did not wane for cancer patients on active treatment or for cancer survivors. The researchers wrote that this was “remarkable given the significant waning demonstrated in the control group from 150 days postvaccination.”

During the omicron wave, there was no significant waning of vaccine effectiveness against severe COVID-19 or hospitalization after 3 doses for either the cancer or the control cohorts. However, vaccine effectiveness against SARS-CoV-2 infection did wane.

“The results of this cohort study provide evidence of the benefit of early vaccination and administration of booster vaccine doses against COVID-19 in patients with cancer, especially in conferring protective effects of vaccination against adverse outcomes of COVID-19,” the researchers wrote. “The findings also provided insight into the longevity of vaccine-mediated protection against clinical infection outcomes in both immunocompromised patients with cancer, with or without active treatment, and the general population.”

Disclosures: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.