The Coronavirus resource center provides clinical news and articles, coverage from conferences and meetings, links to condition-specific resources, and videos and other content.

Visit Our Coronavirus Resource Center

Continuous glucose monitoring (CGM) significantly decreased glycated hemoglobin HbA1C levels for patients with poorly controlled type 2 diabetes (T2D) compared with blood glucose meter monitoring, according to the results of a study published in JAMA.

Although the benefits of CGM for patients with diabetes have been previously demonstrated, the investigators said these benefits have been well established only for patients with type 1 diabetes or T2D treated with multiple daily insulin injections.

However, the study is among the first to demonstrate the benefits of CGM for patients with T2D treated only with basal insulin, a long-acting insulin designed to be injected once or twice daily.

Each participant received 1 or 2 daily injections of long-acting basal insulin with or without non-insulin medications to help lower blood sugar levels. In addition to testing the efficacy of CGM paired with basal insulin, the investigators intended to study how the impact of this diabetes treatment approach affected patients’ disease management adherence and overall life satisfaction.

On average, HbA1c decreased by 1.1% for patients using CGM to manage their diabetes compared with 0.16% for patients using blood glucose meter monitoring.

Further, across all 175 participants, adherence to diabetes management improved, and life satisfaction was higher.

No more finger pricks: a continuous glucose monitor benefits patients with diabetes in more ways than one. News release. ScienceDaily. July 26, 2021. Accessed July 29, 2021. 

https://www.sciencedaily.com/releases/2021/07/210726170357.htm

Articles

News

Diabetes

Retail

CGM Improves Outcomes for Patients Using Only Basal Insulin

AIDS was first described in June 1981 when a report published in the CDC’s 

) documented 5 previously healthy individuals with pneumocystis pneumonia, a disease known to mostly affect severely immunocompromised people.

 In 1983, the virus that causes AIDS was identified; it was later named human immunodeficiency virus (HIV).

The medical community has now strived to eradicate HIV for almost 40 years. During that time, those who work closely with HIV have determined that developing and introducing vaccines is the only way to end the AIDS epidemic.

 However, at this moment, the FDA has not approved any prophylactic or therapeutic HIV vaccines, as candidate vaccines have failed or shown limited and questionable efficacy.

Despite this difficulty, promising new vaccines are being studied. The success of the COVID-19 messenger RNA (mRNA) vaccines from Pfizer/BioNTech and Moderna has given many HIV advocates hope that a preventive mRNA vaccine is on the horizon. Adding to this excitement is a phase 1 clinical trial (NCT05001373) that began in September 2021 studying a sequence of mRNA vaccines that may prevent HIV.

This article discusses NCT05001373 and places the trial in the context of research that paved the way for it, institutions supporting the trial, and other HIV research and vaccines in development.

NCT05001373: ASSESSING AN mRNA HIV VACCINE SEQUENCE

The mRNA vaccine trial (NCT05001373) investigates the hypothesis that vaccination by a germline-targeting prime and then by directional boost immunogens can both provoke B-cell specific class response and steer early maturation toward broadly neutralizing antibody (bnAb) growth through an mRNA platform.

This randomized, first-in-human, open label study examines HIV-1 uninfected adults in good general health. Adults 18 to 50 years of age who apply for the trial and meet all inclusion and no exclusion criteria will be enrolled and randomized. Then, depending upon their assigned group, trial participants will receive either or both of the experimental mRNA vaccines (mRNA- 1644 [eOD-GT8 60mer mRNA], mRNA- 1644v2-Core [Core-g28v2 60mer mRNA]) via intramuscular injection. Safety and tolerability, the primary outcome measure, will be assessed by the proportion of participants with mild, moderate, or severe adverse effects at different times throughout the study. Investigators will also study immunogenicity, the secondary outcome measure, by means of presence and magnitude of relevant immune biomarkers at 10 months.

Investigators estimate an enrollment of 56 participants and study completion by May 1, 2023.

RESEARCH BEHIND THE TRIAL: BNABS AND NCT03547245

The bnAbs of interest in NCT05001373 may be the key to protecting uninfected people from HIV. Whereas other prophylactic vaccines contain a series of the same antigen to induce an immune response, the phase 1 trial tests whether a sequence of immunogens may guide the immune system’s antibody response as it develops naive B cells into mature bnAbs. Mature bnAbs can be traced back to a germline-targeting antigen; vaccine sequencing might then begin with germline targeting and shepherd antibody response to produce mature HIV-fighting cells.

NCT05001373, which is a collaboration principally between International AIDS Vaccine Initiative (IAVI) and ModernaTx, Inc, builds upon the success of NCT03547245, the results of which IAVI and Scripps Research announced in February 2021. The trial demonstrated that the eOD-GT8 60mer vaccine could, indeed, stimulate germline B cells, a first step in bnAb production.

FUTURE DIRECTIONS: OTHER HIV RESEARCH AND VACCINES IN DEVELOPMENT

The vaccine sequence that investigators are studying in NCT05001373 may become a tool to ending the AIDS epidemic. However, researchers are investigating other exciting anti-HIV strategies and vaccines, too.

One such strategy is described by Williams et al in a study published in 

in May 2021. The study investigators examined how glycan-reactive B cells in rhesus macaques and humans evolved in the presence of HIV-1 envelope (Env). They discovered and described what they call Fab-dimerized glycan-reactive (FDG) antibodies, which bind to HIV-1 Env glycans. FDG antibodies neutralize HIV-1 and offer hope that another prophylactic vaccine for humans might be developed.

Therapeutic HIV vaccines also show promise. A prophylactic HIV vaccine would prepare the immune system to recognize and effectively fight HIV in uninfected patients.

 By contrast, therapeutic HIV vaccines are designed to improve the immune response in a person who is already infected. Theoretically, this could slow progression from HIV to AIDS and keep a patient’s viral load at undetectable levels without antiretroviral therapy (ART).

 Research has shown that patients with an undetectable viral load are unable to transmit the virus to others through sexual transmission, a concept known as “U = U” for “Undetectable = Untransmittable.”

Institutions like IAVI and the HIV Vaccine Trials Network (HVTN), headquartered at the Fred Hutchinson Cancer Research Center, are at the forefront of HIV vaccine development.

 A global, publicly funded, multidisciplinary collaborative that facilitates HIV vaccine development, HVTN has conducted over 50 HIV-vaccine-related clinical trials over the past decade.

lists the 8 HIV-vaccine-related studies that are part of the HVTN, currently recruiting, and available on ClinicalTrials.gov.

NCT05001373 represents an important step toward having a widely available HIV preventive vaccine available to the general public. Public health and HIV advocates are patiently awaiting the results of this and other groundbreaking trials with the hopes that ending the HIV epidemic is right around the corner.

Christina M. Madison, PharmD, FCCP, AAHIVP, 

is the founder and CEO of The Public Health Pharmacist, PLLC, in Las Vegas, Nevada.

Curran, JW. Editorial note -- 1996. Reproduced in Pneumocystis pneumonia -- Los Angeles. 

. 1999;48(LMRK):77-81. CDC. June 5, 1981. Accessed September 10, 2021. https://www.cdc.gov/mmwr/preview/mmwrhtml/lmrk077.htm

Barré-Sinoussi F, Chermann JC, Rey F, et al. Isolation of a T-lymphotropic retrovirus from a patient at risk for acquired immune deficiency syndrome (AIDS). 

. 1983;220(4599):868-871. doi:10.1126/science.6189183

Burton DR. Advancing an HIV vaccine; advancing vaccinology. 

. 2019;19(2):77-78. doi:10.1038/s41577-018-0103-6

What is a preventive HIV vaccine? NIH Office of AIDS Research. Accessed September 9, 2021. https://hivinfo.nih.gov/understanding-hiv/fact-sheets/what-preventive-hiv-vaccine

What is a therapeutic HIV Vaccine? NIH Office of AIDS Research. Accessed September 9, 2021. https://hivinfo.nih.gov/understanding-hiv/fact-sheets/what-therapeutic-hiv-vaccine

A phase 1 study to evaluate the safety and immunogenicity of eOD-GT8 60mer mRNA vaccine (mRNA-1644) and Core-g28v2 60mer mRNA vaccine (mRNA-1644v2-Core). ClinicalTrials.gov. Updated August 19, 2021. Accessed September 9, 2021. https://clinicaltrials.gov/ct2/show/NCT05001373

First-in-human clinical trial confirms novel HIV vaccine approach developed by IAVI and Scripps Research. News release. International AIDS Vaccine Initiative. February 3, 2021. Accessed September 16, 2021. https://www.iavi.org/news-resources/ press-releases/2021/first-in-human-clinical-trial-confirms-novel-hiv-vaccine-approach-developed-by-iavi-and-scripps-research

Moderna provides business update and announces three new development programs in infectious disease vaccines. News release. ModernaTx. January 11, 2021. Accessed September 16, 2021. https://investors.modernatx.com/news-releases/news-release-details/moderna-provides-business-update-and-announces-three-new

A phase 1 study to evaluate the safety and immunogenicity of eOD-GT8 60mer mRNA vaccine, Adjuvanted. ClinicalTrials.gov. Updated February 5, 2020. Accessed September 16, 2021. https://clinicaltrials.gov/ct2/show/NCT03547245

Williams WB, Meyerhoff RR, Edwards RJ, et al. Fab-dimerized glycan-reactive antibodies are a structural category of natural antibodies. 

. 2021;184(11):2955-2972.e25. doi:10.1016/j.cell.2021.04.042

HIV undetectable=untransmittable (u=u), or treatment as prevention. National Institute of Allergy and Infectious Diseases. Reviewed May 21, 2019. Accessed September 17, 2021. https:// www.niaid.nih.gov/diseases-conditions/treatment-prevention

About. HIV Vaccine Trials Network. Accessed September 17, 2021. https://www.hvtn.org/en/about.html

HVTN | Recruiting studies | HIV. ClinicalTrials.gov. Accessed September 9, 2021. https://clinicaltrials.gov/ct2/results?term=HVTN&cond=HIV&Search=Apply&recrs=a&age_v=&gndr=&type=&rslt=

Analytical treatment interruption (ATI) to assess the immune system’s ability to control HIV in participants who became HIV-infected during the HVTN 704/HPTN 085 AMP study. ClinicalTrials.gov. Updated September 14, 2021. Accessed September 17, 2021. https://clinicaltrials.gov/ct2/show/NCT04801758?term=HVTN&recrs=a&cond=HIV&draw=2&rank=1

Analytical treatment interruption (ATI) to assess the immune system’s ability to control HIV in participants who became HIV-infected during the HVTN 703/HPTN 081 AMP study. ClinicalTrials.gov. Updated September 5, 2021. Accessed September 17, 2021. https://clinicaltrials.gov/ct2/show/NCT04860323

Evaluating safety and immune response to the HIV-1 CH505 transmitted/founder gp120 adjuvanted with GLA-SE in Healthy, HIV-exposed uninfected infants (HVTN 135). ClinicalTrials. gov. Updated December 31, 2020. Accessed September 17, 2021. https://clinicaltrials.gov/ct2/show/NCT04607408

Evaluating the safety and immunogenicity of stabilized CH505 TF chTrimer in healthy, HIV-uninfected adult participants. ClinicalTrials.gov. Updated June 7, 2021. Accessed September 17, 2021. https://clinicaltrials.gov/ct2/show/NCT04915768

Evaluating the safety and immunogenicity of HIV-1 BG505 SOSIP.664 gp140 with TLR agonist and/or alum adjuvants in healthy, HIV-uninfected adults. ClinicalTrials.gov. Updated September 2, 2021. Accessed September 17, 2021. https://clinicaltrials.gov/ct2/show/NCT04177355

Evaluating the safety and immunogenicity of EnvSeq-1 and CH505 M5 gp120 Envs adjuvanted with GLA-SE in healthy, HIV-uninfected adults. ClinicalTrials.gov. Updated May 18, 2021. Accessed September 17, 2021. https://clinicaltrials.gov/ct2/show/ NCT03220724

Evaluating the safety, tolerability, pharmacokinetics, and antiviral activity of the monoclonal antibody PGT121.414.LS administered alone and in combination with VRC07-523LS via intravenous or subcutaneous infusions in healthy, HIV-uninfected adult participants. ClinicalTrials.gov Updated August 4, 2021. Accessed September 17, 2021. https://clinicaltrials.gov/ct2/ show/NCT04212091

A study of heterologous vaccine regimen of adenovirus serotype 26 Mosaic4 human immunodeficiency virus(ad26.Mos4.Hiv), adjuvanted Clade c gp140 and Mosaic gp140 to prevent HIV-1 infection among cis-gender men and transgender individuals who have sex with cis-gender men and/or transgender individuals (MOSAICO). ClinicalTrials.gov. Updated September 1, 2021. Accessed September 17, 2021. https://clinicaltrials.gov/ct2/show/ NCT03964415


The success of the COVID-19 messenger RNA (mRNA) vaccines from Pfizer/BioNTech and Moderna has given many HIV advocates hope that a preventive mRNA vaccine is on the horizon.

Immunization

Hospital

Using mRNA to Create the Elusive HIV Vaccine

made clear the essential role pharmacists play in immunizations, and as booster shots and the flu season approach, patients will continue to turn to pharmacists for necessary vaccines, according to a panel of experts in a recent 

The webcast participants discussed the opportunities that pharmacists have to expand their services through immunizations.

Pharmacies have been providing immunizations for more than 20 years, though the public recognition of this role has increased exponentially during the COVID-19 pandemic, according to webcast moderator Ed Cohen, PharmD, FAPhA, executive vice president of pharmacy advocacy at MJH LifeSciences™, the parent company of 

Panelist Suzanne Soliman, PharmD, BCMAS, founder of the Pharmacist Moms Group, said she agrees that gaining recognition for these services has been a major change over the past year, adding that some surveys have found that many patients prefer to get COVID-19 vaccines at local pharmacies instead of large, mass vaccination sites.

“It’s very clear that pharmacy is on the trajectory to become the center of this place, and I think pharmacists have been embracing this new role,” Soliman said.

The trust that patients place in pharmacists goes beyond the retail environment. Panelist Liz Oler, PharmD, patient care services coordinator of immunizations and advanced clinical services at Albertsons Companies, said that pharmacists are also trusted to provide immunizations in community centers, schools, and workplaces.

Contracting with employer groups or schools is a great way to bring awareness about pharmacy services to the public, she said.

In addition to creating more widespread awareness about the role of pharmacies in immunizations, the COVID-19 pandemic resulted in new opportunities and privileges from boards of pharmacy and waivers. Although some of these privileges could last beyond the pandemic, Cohen said some could be revoked.

Many states passed rules allowing pharmacy technicians to administer vaccinations, and the Public Readiness and Emergency Preparedness Act greatly expanded those opportunities, Oler said These privileges vary by state, with some requiring collaborative practice agreements and limiting which vaccines can be administered or which age groups can receive them at pharmacies.

In states that might be considering reinstating limitations or revoking these privileges, panelist Jennifer Adams, PharmD, EdD, associate dean for academic affairs at Idaho State University College of Pharmacy, said now is the time to advocate.

“We’ve demonstrated over the course of the past year what we’re capable of as a profession across the United States,” she said. “It’s time we begin to advocate across all the states to get the point of being progressive, like we are here in Idaho.”

The pandemic also resulted in many delayed routine medical visits, including delays in immunizations for children. When speaking with parents, pharmacists have a big role to play in ensuring that children catch up on their immunizations.

Soliman said she is seeing nearly 15% catch-up rates in pediatric immunizations, and she recommended some ways in which pharmacists can get involved in this effort in their communities.

“Serving on some of the public health boards for our own towns can help make a difference in some of the schools and with some of the children,” Soliman said, noting that the closure of preschools has meant fewer reminders for parents to get their children’s routine immunizations. “Pharmacists can get a lot more involved in that.”

With all these simultaneous issues, and as pharmacies prepare for COVID-19 booster shots and flu vaccinations, the panelists all agreed that they are incredibly proud of the profession. Collaborating with other health care professionals will be essential to managing the workload and ensuring holistic patient care.

“Pharmacy has a big role to play in public health, whether it’s a pandemic or a natural disaster,” said panelist John Beckner, BS Pharm, senior director of strategic initiatives at the National Community Pharmacists Association. “And we need to continue to work with our colleagues in the public health sector to collaborate.”

Community pharmacy: center of immunization services. 

Accessed September 14, 2021. https://www. pharmacytimes.com/webinars-webcasts/community-pharmacy-center-of-immunization-services

Public recognition of their role has increased exponentially during the COVID-19 pandemic.

Publications

Pharmacies Play Key Role as Center of Immunization Services

 interviewed Gary Locke, former executive of King County, governor of Washington state, US Secretary of Commerce, and ambassador to China under the Obama administration, to discuss the World Trade Organization's TRIPS Council. The council convened on October 13 and 14 to assess a proposed waiver to the TRIPS Agreement that would eliminate IP protections for COVID-19 vaccines, diagnostics, and medical devices—potentially permanently.

During the discussion, Locke addressed why the misconception persists regarding the value of eliminating IP protections for COVID-19 vaccines in order to increase global vaccinations, investments that countries such as the United States could make that would be beneficial in the fight against the pandemic abroad, what some of the lasting ramifications of the elimination of IP protections for COVID-19 vaccines may be for US research and development, and what his hopes are for the future in relation to the world’s approach to fighting the spread of the coronavirus.

Videos

Gary Locke, former governor of Washington state, US Secretary of Commerce, and ambassador to China, discusses the World Trade Organization's TRIPS Council, which recently met to assess the elimination of IP protections for COVID-19 vaccines, diagnostics, and medical devices.

Coronavirus

Expert: Eliminating IP Protections for COVID-19 Vaccines Would Not Fix the Immediate Need for More Vaccinations Globally

In an interview with Pharmacy Times, Walgreens Chief Medical Officer Kevin Ban, MD, said the Walgreens 2021-2022 Flu Index is showing high flu activity in several regions of the country. Notably, Ban said the highest levels so far have been seen in Las Vegas and the state of Nevada, more broadly.

Ban said these findings are interesting to compare with data from the 2020-2021 flu season, which were markedly lower than normal. This could be explained by several causes, including higher rates of vaccination last year and COVID-19-related protective measures, including mask wearing and hand hygiene, according to Ban.

Walgreens Chief Medical Officer Kevin Ban, MD, said the Walgreens 2021-2022 Flu Index is showing high flu activity in several regions of the country.

Interviews

Data Show High Flu Activity Early in the Season

 interviewed Adam Olszewski, MD, associate professor of medicine in Alpert Medical School at Brown University, to discuss his SOHO 2021 conference presentation on prognostication and treatment of Burkitt lymphoma in the modern era.

 What is Burkitt lymphoma and is there a patient population particularly affected by the disease?

Thanks for having me. Burkitt lymphoma is a very interesting disease. It's a rare subtype of non-Hodgkin lymphoma that maybe for adults constitutes only 1% of all cases of non-Hodgkin lymphoma; it is probably more common in the pediatric population. I’m an adult hematologist, so I treat mostly adults.

It is considered to be the fastest growing human cancer and the main characteristic of these diseases is probably that it is a composed of very rapidly dividing cells, of which essentially 100% are undergoing division at any point in time. It is famous for a doubling in volume, sometimes within 24 hours.

This is not universal; there are some cases which curiously grow slower, but it's challenging for oncologists because of the rapidity of its growth, with rapid spread to nodal and extranodal organs and the intensity of treatment that is required to cure it.

Another peculiar thing about Burkitt lymphoma is it is consider a highly curable disease. As long as the treatment is executed expertly and expeditiously, the general belief is that patients should be cured.

It is interestingly affecting younger patients compared to maybe other aggressive B-cell lymphomas, like diffuse large B-cell or high grade B-cell lymphoma, in which the median age is in the 40s, there's a lot of pediatric patients. We also know that there are 3 sub categories or variants of Burkitt lymphoma which somewhat related to the risk factors for it, so that it was called endemic Burkitt lymphoma, which is associated with the Epstein-Barr virus infection, and this variant predominates in the equatorial strip in Africa, Papua New Guinea, and other areas geographically.

Then there's the immunodeficiency-associated variant, which in western countries is mostly observed in patients who have HIV infection, so that's a major risk factor, and probably, at this point, it’s one of the most common lymphomas that are diagnosed among patients with the HIV infection. It characteristically is diagnosed in patients who have fairly good control of their infection, with good CD4 counts, sometimes undetectable viral load.

Then, the large majority of patients in the United States are patients with sporadic Burkitt lymphoma, which kind of happens randomly.

Adam Olszewski, MD, associate professor of medicine in Alpert Medical School at Brown University, discusses his SOHO 2021 conference presentation on prognostication and treatment of Burkitt lymphoma in the modern era.

Oncology

Conference

Specialty Pharmacy

Overview of Burkitt Lymphoma, the Patient Populations Most Impacted

Merck announced positive top-line results from two pivotal phase 3 trials of the once-a-day combination pill of doravirine/islatravir (DOR/ISL) for individuals with HIV-1 who are virologically suppressed on different antiretroviral therapy regimens (ART), the company said in a statement.

“We are encouraged by the results from the Phase 3 ILLUMINATE SWITCH A and B trials, in which the DOR/ISL dual regimen efficacy was comparable to certain commonly used 3-drug regimens,” Joan Butterton, MD, vice president of global clinical development and infectious diseases at Merck Research Laboratories, said in the statement. “We will continue to study doravirine/islatravir in diverse populations of people living with HIV and look forward to sharing data from these trials.”

Both trials met the primary efficacy endpoint of percentage of individuals with HIV-1 RNA levels ≥50 copies/mL. The safety and tolerability profile of DOR/ISL during the trials are consistent with previously reported phase 2 studies.

The ILLUMINATE clinical trials included individuals with HIV-1 who are virologically suppressed on ART, those who are heavily treatment experienced, and those who are new to HIV treatment. The program also included pediatric individuals with HIV-1 weighing at least 77.1 pounds who are virologically suppressed and have been treated.

Doravirine is approved for the treatment of individuals with HIV-1 in combination with other antiretrovirals as a single agent and a component of a single-tablet regimen. Islatravir, created by Merck, is an investigational nucleoside reverse transcriptase translocation inhibitor under evaluation for the treatment of individuals living with HIV-2 infection in combination with other antiretrovirals.

Merck announces positive top-line results from pivotal phase 3 trials evaluating investigational, once-daily oral fixed dose combination of Doravirine/Islatravir for the treatment of people with HIV-1 infection. Merck. News release. October 25, 2021. Accessed October 25, 2021. 

https://www.merck.com/news/merck-announces-positive-top-line-results-from-pivotal-phase-3-trials-evaluating-investigational-once-daily-oral-fixed-dose-combination-of-doravirine-islatravir-for-the-treatment-of-people-with-hiv-1/

Phase 3 ILLUMINATE showed the percentage of individuals with HIV-1 RNA levels ≥50 copies/mL for the once-a-day combination pill of doravirine/islatravir.

Merck’s Doravirine and Islatravir Met Primary Endpoints for Treatment of HIV-1

Officials with the FDA have approved Roche’s VENTANA PD-L1 (SP263) Assay as a diagnostic test to evaluate patients with non-small cell lung cancer (NSCLC) who are eligible to receive atezolizumab (Tecentriq, Genentech).

Atezolizumab received FDA approval on October 15, 2021, as adjuvant treatment following surgery and platinum-based chemotherapy for adults whose stage II-IIIA NSCLC tumors have programmed death ligand-1 (PD-L1) expression on ≥1% of tumor cells. The VENTANA PD-L1 (SP263) Assay is designed to identify patients with NSCLC who are eligible to receive atezolizumab monotherapy for this indication.

“Early detection of lung cancer can change the treatment pathway for patients and give them more treatment options,” said Thomas Schinecker, CEO of Roche Diagnostics, in a press release. “We are proud to offer a companion diagnostic PD-L1 test that identifies lung cancer patients who may qualify for Tecentriq therapy. With the FDA approval of this companion diagnostic test, clinicians now have an effective tool for offering better patient care through targeted immunotherapy treatment.”

Currently, the standard of care for patients with early-stage lung cancer is surgery to remove the tumor, potentially followed by chemotherapy. According to investigators, approximately 50% of patients given this treatment will have their cancer return after surgery.

In the IMpower010 study—initiated in 2015 to determine how patients respond to atezolizumab following surgery and chemotherapy—the VENTANA PD-L1 (SP263) Assay was used to identify patients whose tumors expressed the PD-L1 protein. In 2021, the investigators reported a 34% reduction in the risk of disease recurrence or death in patients receiving atezolizumab whose tumors were shown to express PD-L1 protein.

Roche’s VENTANA PD-L1 (SP263) Assay receives FDA approval as a companion diagnostic to identify certain non-small cell lung cancer patients eligible for Tecentriq® (atezolizumab) [news release]. Roche; October 22, 2021. Accessed October 22, 2021. 

https://www.roche.com/media/releases/med-cor-2021-10-22.htm

Officials with the FDA have approved Roche’s VENTANA PD-L1 (SP263) Assay as a diagnostic test to evaluate patients with non-small cell lung cancer (NSCLC) who are eligible to receive atezolizumab (Tecentriq, Genentech). 

Lung Cancer

FDA Approves PD-L1 Test To Evaluate Patients With NSCLC Eligible to Receive Atezolizumab

The FDA granted Fast Track Designation to nemvaleukin alfa (nemvaleukin; Alkermes), an investigational interleukin-2 variant immunotherapy, for the treatment of platinum-resistant ovarian cancer, according to a statement from Alkermes.

“This Fast Track Designation in platinum-resistant ovarian cancer highlights the potential clinical utility of nemvaleukin in combination with pembrolizumab in this difficult-to-treat disease for which there is no approved immunotherapy, and there remains significant need for new treatment options,” Craig Hopkinson, MD, chief medical officer and executive vice president of research and development at Alkermes, said in the statement.

The FDA previously granted Fast Track Designation and Orphan Drug Designation to nemvaleukin for the treatment of mucosal melanoma, in addition to the new designation.

Nemvaleukin is intended to be used in combination with pembrolizumab, an anti-PD-1 antibody.

Fast Track is designed to facilitate the development and expedite the review of different therapies for treatment of serious conditions and fill unmet medical needs.

Alkermes receives FDA Fast Track Designation for Nemvaleukin Alfa in combination with Pembrolizumab for the treatment of platinum-resistant ovarian cancer. Alkermes. News release. October 25, 2021. Accessed October 25, 2021. 

https://investor.alkermes.com/news-releases/news-release-details/alkermes-receives-fda-fast-track-designation-nemvaleukin-alfa-0

The drug previously received approval to treat mucosal melanoma but could be used in combination with pembrolizumab.

Ovarian Cancer

FDA Grants Fast Track Designation to Nemvaleukin as Treatment for Ovarian Cancer

The administration of V114, a 15-valent pneumococcal conjugated vaccine (PCV), had a comparable number of antibody levels compared to PCV13, 12-valent, followed by a 23-valent pneumococcal polysaccharide vaccine in adults 50 years of age or older, according to the results of a study published by 

Thirty days after vaccination, the immune response to serotype 3, which is the most common serotype of pneumococcal disease, was higher in the V113 group than the PCV13 group, whereas serotype 4 was slightly lower.
Also, all 15 serotypes in the vaccine induced an immune response that was higher for the serotypes unique to V114 than in PCV13 and were comparable for the 13 shared serotypes.

The opsonophagocytosis (OPA) titers and immunoglobulin G (IgG) response declined between day 30 and month 12 but were still higher than at day 1 for both V114 and PCV13. The antibody protection for up to 12 months post-vaccination was comparable between the shared serotypes in both vaccines, according to the study.

The administration of PPSV23 following V114 elicited an immune response to all 15 serotypes. OPA IgG responses 30 days after the PPSV23 vaccine was administered were comparable to the serotypes’ levels 30 days after the PCV vaccination, according to the study.

Serum samples of the individuals were collected before the PCV vaccine on day 1, 30 days after the PCV vaccination, before the PPSV23 vaccination at 12 months, and 30 days after the PPSV23 vaccination.

The study was conducted from June 2018 to December 2019 at 22 sites including, in the United States, Republic of Korea, Spain, and Taiwan. There were 600 individuals in the study who received either the V114 or PCV13 vaccine on a 1 to 1 basis, followed by the PPSV23 vaccination 12 months later.

The individuals enrolled in the study were 50 years of age or older and generally in good health and/or had stable underlying medical conditions.

Approximately 1 to 5 days after the vaccination, injection-site reactions such as erythema, swelling, and pain occurred. From 1 to 14 days after the vaccination, muscle pain, joint pain, headache, and fatigue could occur, according to the study.

Song J, Chang, C, Andrews C, Diez-Domingo J, et al. Safety, tolerability, and immunogenicity of V114, a 15 valent pneumococcal conjugate vaccine, followed by sequential PPSV23 vaccination in healthy adults aged ≥50 years: a randomized phase III trial (PNEU-PATH). 

2021;S0264-410X(21)01071-9 doi:10.1016/j.vaccine.2021.08.038

The immune response of all 15 serotypes in the V114 pneumococcal vaccination were higher than those in the PCV13 vaccination.

Latest Clinical News