Innovations in medicine occur all the time. Some happen quickly, like the unprecedented speed with which the COVID-19 vaccines were developed. Others take more time to develop, as researchers leverage current knowledge and new ideas to develop novel pathways toward diagnoses, treatments, and survival for patients with a wide variety of diseases.
Each month, we dive deep into lab reports, journals, and conferences to bring you the most highly anticipated innovations coming down the pike for one of the most dreaded diseases: cancer. This month, in honor of Cervical Cancer Awareness Month, our focus is on cervical cancer. Among the new developments to keep an eye on:
High-Resolution Digital Images Improve Diagnostic Accuracy in Real-Time
Israeli startup Illumigyn has developed the world’s first gynecological remote imaging platform, the Gynescope, which allows practitioners to capture high-definition images of the cervix, vagina, and external genital parts for more accurate diagnosis than standard Pap smears. A midwife or other healthcare provider can conduct a Gynescope exam in the privacy of a patient’s home, uploading the images for review by a clinical specialist. Additionally, storage in the cloud offers patients better control over their data and images, making follow up and second opinions easier.
Next Step Gynescope was cleared for use by the FDA in early 2019 but the company continues to raise funding to support research and development and global rollout of the tool. One important advance under development is the artificial intelligence (AI) Clinical Decision Making Support Software, which will provide patients the ability to immediately access a second opinion.
Clinical Trial Will Examine Experimental Cellular Therapy for Persistent, Recurrent, or Advanced Human Papillomavirus (HPV) Related Cancers
An investigational phase 1 study is recruiting adult men and women with persistent, recurrent, or metastatic cancer related to HPV type 16 (HPV16)-associated cancers (cervical, anal, and head and neck cancers) to test a new cellular therapy agent RTX-321. The study will determine whether RTX-321 is well tolerated and gauge the most effective dose and dosing strategy. RTX-321 is a new type of treatment that relies on removing and modifying certain cells from the blood, then reinjecting them into the patient to improve the immune system’s ability to target and fight certain types of cancer that have persisted or progressed despite chemotherapy, radiation, and other treatments.
Next Step The 30-month trial is slated to end in September 2023. If proven safe and effective, investigators will continue to test RTX-321 in a phase 2 trial in larger numbers of patients and possibly, different types of cancers, to see if it stops disease progression.
Machine 'Deep Learning' Reduces False-Positive Labs, Unnecessary Follow-Up
Interest in an artificial-intelligence (AI) deep machine learning strategy for cervical cancer screening is growing, according to an editorial published in the November 2021 issue of the Journal of the National Cancer Institute. The approach uses a slide imaging platform that is housed in the cloud and focuses on two specific biomarkers that have been closely linked to cervical cancer. In the editorial, the authors write that not only are false-positive results reduced, but that referrals for follow-up colposcopy exams (which allow the practitioner to more closely examine the cervix for abnormal cells) by almost one-third.
Next Step The editorial authors state that this strategy is possibly the first of its kind to be comprehensively analyzed for cervical cancer screening. What’s more, it’s also been validated in three larger studies. Importantly, because it is cloud-based, it allows the analysis to take place anywhere in the world. Now, a mechanism that allows these images to be shared, perhaps by cell phone — needs to be developed so that the technology can be fully realized.
Combined T Cell–Based Treatment and Immune Checkpoint Inhibitor Doubles Response Rates
Data presented November 14 at the Society for Immunotherapy of Cancer Annual Meeting shows that combining an experimental drug, lifleucel, with the immunotherapy drug Keytruda (pembrolizumab) roughly doubles response rates in a variety of cancers, including stage 4 cervical cancer. Lifelucel enhances the response of a patient’s own immune cells, specifically T cells, in recognizing and fighting cancer. In this trial, 57 percent of patients with cervical cancer responded to treatment, and 71 percent were continuing to respond at the 7.6 month follow-up. In a press release, Freiedrich Graf Finckelstein, MD, chief medical officer at Iovance Biotherapeutics, which developed the drug, noted that “response rates are nearly double compared to what was seen with single-agent pembrolizumab.”
Next Step Because early findings are so promising, investigators will be expanding the study to enroll more patients. The company is also continuing investigations into the use of tumor infiltrating lymphocyte (TIL) T cell–based therapy combinations for early-line treatment in advanced, solid tumor cancers.
A Single Dose HPV Vaccine Delivers Promising News
Just one dose of the human papillomavirus (HPV) vaccine appears to be almost 98 percent effective against HPV according to research presented on November 17 at the 34th International Papillomavirus Conference. In the study, African women between the ages of 15 and 20 years received one of three vaccines: a bivalent vaccine that covers two HPV strains (types 16 and 18), which represent 70 percent of cases; a nonvalent vaccine that covers 7 HPV strains (types 16, 18, 3, 33, 45, 52, and 58), which represent 90 percent of cases; or a non-HPV vaccine against meningococcal meningitis. At the 18-month follow-up, findings showed that both the bivalent and nonvalent vaccines were 97.5 percent effective against HPV types 16 and 18, and the nonvalent 89 percent effective against HPV types 16, 18, 31, 33, 45, 52, and 58.
Next Step This is the first time that a single-dose HPV vaccine has been shown to protect against HPV. The current standard is three doses. While more study is needed, especially to determine how long protection might last, the findings might help the World Health Organization (WHO) achieve 90 percent coverage in 15 year-old girls by 2030. It also provides an important alternative strategy to three-dose regimens that often challenge the ability of underserved countries and populations to efficiently deliver vaccines. In a press release, WHO Director General Tedros Adhanom Ghebryesus, PhD, noted that, globally, cervical cancer kills women every two minutes, but that most of these deaths are in Africa, which bears 80 percent of the burden of cervical cancer.