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Balstilimab, Zalifrelimab Active in Advanced Cervical Cancer

Checkpoint blockade with the PD-1 inhibitor balstilimab, alone or in combination with the anti-CTLA-4 drug zalifrelimab, showed activity in women with recurrent or metastatic cervical cancer, preliminary results from two phase II trials indicated.

In patients treated with balstilimab alone, the overall response rate (ORR) was 14%, including complete responses in 2%, reported David O’Malley, MD, of the Ohio State University Comprehensive Cancer Center in Columbus.

And in those who received both investigational agents — balstilimab plus zalifrelimab — the ORR increased to 22%, including complete responses in 6%.

“What is really interesting about the combination arm is that while we did see a median duration of response in the single-agent [arm] that was a very impressive 15 months, the duration of response has not been reached in the combination arm,” O’Malley told MedPage Today.

He said that the tripling of the complete response rate as well as the better duration of response suggest that combination immunotherapy may be “the future of cervical cancer treatment.”

Each of the studies involved women with recurrent or metastatic cervical cancer from cancer centers across the U.S. and Europe who previously received platinum-based chemotherapy as first-line treatment.

“These are the two largest trials of immunotherapy in recurrent metastatic cervical cancer that have been reported thus far,” he said.

In the single agent trial, 160 women were given balstilimab at 3 mg/kg every 2 weeks, while in the second trial balstilimab was evaluated in 155 women at the same dosage in combination with zalifrelimab at a dose of 1 mg/kg every 6 weeks. Findings from the trials were recently presented by O’Malley at the 2020 European Society for Medical Oncology virtual congress.

O’Malley emphasized that in both trials there were responders who were PD-L1 negative. In the single agent trial the ORRs were 19% for those with PD-L1-positive disease and 10% for those with PD-L1-negative disease, while in the combination trial those rates were 27% and 11%, respectively.

Furthermore, O’Malley noted, when broken down by histology, the ORR was higher in patients with squamous cell carcinoma who received the combination therapy (27% vs 18% with balstilimab alone), while the ORRs were higher with single-agent balstilimab for patients with adenocarcinoma, adenosquamous, or other histology (8% vs 5% with the combination).

Histology may be a main predictor of response rather than PD-L1 status, O’Malley suggested.

“We reported similar response rates in our squamous cell carcinoma patients as we saw in the PD-L1-positive patients,” he said. “But when we looked at the adenocarcinoma and adenosquamous patients, we saw the rates were similar to PD-L1-negative patients. This calls into question whether the better predictor of response is histology rather than PD-L1 status, and that may be something to look at in the future.”

Regarding a comparison of balstilimab with pembrolizumab (Keytruda), O’Malley pointed out that pembrolizumab has only been approved for women with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1.

“We know that these drugs are more similar than they

HPV vaccine ‘substantially’ reduces cervical cancer risk: study

Human papillomavirus (HPV) vaccination substantially lowered the risk of cervical cancer, especially when administered early, according to a new study.

Researchers in Sweden published their findings on Thursday in the New England Journal of Medicine, and said evidence was otherwise lacking on the issue.

The study found that those vaccinated before age 17 had an 88% lower risk of cervical cancer than those never vaccinated.

Human papillomavirus (HPV) vaccination substantially lowered the risk of <a data-cke-saved-href="https://www.foxnews.com/category/health/cancer/cervical-cancer" href="https://www.foxnews.com/category/health/cancer/cervical-cancer" target="_blank">cervical cancer</a>, especially when administered early, per a new study.<br data-cke-eol="1">
(iStock)

Human papillomavirus (HPV) vaccination substantially lowered the risk of <a data-cke-saved-href=”https://www.foxnews.com/category/health/cancer/cervical-cancer” href=”https://www.foxnews.com/category/health/cancer/cervical-cancer” target=”_blank”>cervical cancer</a>, especially when administered early, per a new study.<br data-cke-eol=”1″>
(iStock)

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“HPV is the most common sexually transmitted infection,” according to the Centers for Disease Control and Prevention (CDC). Those with weakened immune systems may have more difficulty fighting the virus, which can lead to health issues like genital warts and cancers. The CDC recommends two doses of the HPV vaccine for boys and girls aged 11 to 12, though vaccination can start as young as age 9. Pushing off vaccination may result in needing three doses instead of two, the agency said.

The study followed nearly 1.7 million females ages 10 to 30 living in Sweden from 2006 through 2017 to find the association between HPV vaccination and the risk of cervical cancer. Among those vaccinated, 438,939, or 83%, started vaccination before age 17.

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Early vaccination is associated with lower risk of cervical cancer, per the study. (iStock)

Early vaccination is associated with lower risk of cervical cancer, per the study. (iStock)

Cervical cancer was diagnosed in 19 women who were vaccinated and 538 women who were not.

“Although the efficacy and effectiveness of the HPV vaccination against HPV infection, genital warts, and high-grade cervical lesions have been established, our results extend this knowledge base by showing that quadrivalent HPV vaccination is also associated with a substantially reduced risk of invasive cervical cancer, which is the ultimate intent of HPV vaccination programs,” study authors wrote.

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HPV Vaccination and Substantial Reduction in Cervical Cancer

Quadrivalent human papillomavirus (HPV) vaccination was associated with a substantial reduction in the incidence of cervical cancer in a Swedish review of more than 1 million girls and women vaccinated from 2006–2017.

It’s been shown that the vaccine (Gardasil) helps prevent genital warts and high-grade cervical lesions, but until now, data on the ability of the vaccine to prevent cervical cancer, although widely assumed, had been lacking.

“Our results extend [the] knowledge base by showing that quadrivalent HPV vaccination is also associated with a substantially reduced risk of invasive cervical cancer, which is the ultimate intent of HPV vaccination program,” said investigators led by Jiayao Lei, PhD, a researcher in the Department of Medical Epidemiology and Biostatistics at the Karolinska Institute, Stockholm, Sweden.

The study was published online October 1 in The New England Journal of Medicine.

“This work provides evidence of actual cancer prevention,” commented Diane Harper, MD, an HPV expert and professor in the Departments of Family Medicine and Obstetrics & Gynecology at the University of Michigan, Ann Arbor, Michigan. She was the principal investigator on the original Gardasil trial.

This study “shows that the quadrivalent HPV vaccine provides prevention from the sexually transmitted HPV infection that actually reduces the incidence of cervical cancer in young women up to 30 years of age,” she said when approached for comment.

However, she also added a note of caution. These new results show “that vaccinated women still develop cervical cancer, but at a slower rate. This makes the connection between early-age vaccination and continued adult life screening incredibly important,” Harper told Medscape Medical News

Cervical cancer was diagnosed in 19 of the 527,871 women (0.004%) who had received at least one dose of the vaccine, vs 538 among the 1,145,112 women (0.05%) who had not.

The cumulative incidence was 47 cases per 100,000 vaccinated women and 94 cases per 100,000 unvaccinated women. The cervical cancer incidence rate ratio for the comparison of vaccinated vs unvaccinated women was 0.37 (95% CI, 0.21 – 0.57).

The risk reduction was even greater among women who had been vaccinated before the age of 17, with a cumulative incidence of four vs 54 cases per 100,000 for women vaccinated after age 17. The incidence rate ratio was 0.12 (95% CI, 0.00 – 0.34) for women who had been vaccinated before age 17, vs 0.47 (95% CI, 0.27 – 0.75) among those vaccinated from age of 17 to 30 years.

Overall, “the risk of cervical cancer among participants who had initiated vaccination before the age of 17 years was 88% lower than among those who had never been vaccinated,” the investigators noted.

These results “support the recommendation to administer quadrivalent HPV vaccine before exposure to HPV infection to achieve the most substantial benefit,” the investigators said.

Details of the Swedish Review

For their review, Lei and colleagues used several Swedish demographic and health registries to connect vaccination status to incident cervical cancers, using the personal identification numbers Sweden issues to residents.

Participants were followed starting