Caitlin Mollison, Managing Editor

Kite, a Gilead Company, has released positive longer-term follow-up results from 2 pivotal studies of the CAR T-cell therapy Tecartus (brexucabtagene autoleucel). 

The 3-year follow-up of ZUMA-2, a global, multi-center, phase 2 study evaluating the efficacy of Tecartus in patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL), and 2-year follow-up of ZUMA-3, a global, multi-center, open-label, single-arm phase 1/2 study evaluating Tecartus in adult patients with R/R B-cell acute lymphoblastic leukemia (B-ALL) were both presented during a poster session at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting. Three-year follow-up data from ZUMA-2 were also simultaneously published in ASCO’s 

“We are very encouraged by the totality of these data, which suggest a significant and sustained response with Tecartus for people living with difficult-to-treat blood cancers like MCL and B-ALL,” Frank Neumann, MD, PhD, senior vice president and global head of clinical development at Kite said in a statement. “These longer-term results add to the growing maturity of data on Kite’s CAR T-cell therapies.”

At a median of 35.6 of follow-up in the ZUMA-2 trial, the overall response rate (ORR) was 91%, with 68% of treated patients achieving a complete response (CR; 95% CI, 55.2–78.5). The median duration of response (DOR) was 28.2 months, with 37% of treated patients in ongoing response at data cut-off. Median overall survival (OS) among treated patients was 46.6 months. Among those patients who achieved a CR, the median OS has not yet been reached, with the 30-month OS rate at 60.3%. Late relapse, classified as more than 24 months post-infusion, was infrequent (n=3).

“There remains a significant need among patients living with MCL for therapies that provide a long-term response, as many patients have high-risk disease that is more likely to relapse or progress following multiple lines of treatment,” Michael Wang, MD, ZUMA-2 Lead Investigator and Puddin Clarke Endowed Professor, Department of Lymphoma and Myeloma, division of cancer medicine at The University of Texas MD Anderson Cancer Center, said in the statement. “The 3-year data from ZUMA-2 represent the longest follow-up for a CAR T-cell therapy in MCL patients to date and are impressive in their demonstration of brexu-cel to elicit durable long-term responses.”

In the ZUMA-3 trial, longer follow-up of the pivotal analysis and outcomes of a newly conducted larger pooled analysis of phase 1 and 2 patients by independent review who received the pivotal dose of Tecartus were reported. Most patients in the analysis were heavily pre-treated, with a median of 2 prior therapies, and 47% had received 3 or more prior therapies. At a median follow-up of 29.7 months for pooled phase 1 and 2 patients, 73.1% of treated patients achieved a CR or CR with incomplete hematological recovery (CRi). Median OS was 25.4 months for both phase 2-treated patients and pooled phase 1 and 2 treated patients. At data cutoff, median OS had not yet been reached in phase 2 patients who achieved a CR. Similar outcomes among phase 2 treated patients (n=55) and the pooled analysis of phase 1 and 2 patients (n=78) were observed.

Tecartus® Car T-cell therapy demonstrates strong overall survival rates and continued durable responses in long-term follow-up of two pivotal studies including longest ever follow-up of a CAR T-cell therapy in mantle cell lymphoma. Gilead. News release. June 4, 2022. Accessed June 5, 2022. https://www.gilead.com/news-and-press/press-room/press-releases/2022/6/tecartus-car-t-cell-therapy-demonstrates-strong-overall-survival-rates-and-continued-durable-responses-in-long-term-follow-up-of-two-pivotal-studies

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Three-year follow-up analysis shows that Gilead’s car T-cell therapy induced high rates of durable response and a median overall survival of 46.6 months.

Tecartus for Mantle Cell Lymphoma Demonstrates Positive Data in Latest Study

Updated results from the ELEVATE-TN phase 3 trial showed AstraZeneca’s Calquence (acalabrutinib) maintained a statistically significant progression-free survival (PFS) benefit versus chlorambucil plus obinutuzumab and a safety and tolerability profile consistent with the known profile for Calquence at a median follow up of approximately 5 years in combination and as a monotherapy in chronic lymphocytic leukemia (CLL), the company said in a statement.

Results also showed longer overall survival (OS) for Calquence combined with obinutuzumab compared with chlorambucil combined with obinutuzumab in previously untreated adults with CLL, the company said.

CLL is the most prevalent type of leukemia in adults, with more than 100,000 patients diagnosed globally in 2019, according to the company.

At a median follow-up of 58.2 months, Calquence plus obinutuzumab reduced the risk of disease progression or death by 89%, based on a hazard ratio (HR) of 0.11, 95% confidence interval (CI) 0.07-0.16, and as a monotherapy by 79%, based on a HR of 0.21, 95% CI 0.15-0.30, compared with chlorambucil plus Obinutuzumab, the company said. 

OS data are immature, and medians were not yet reached in any treatment arm, the company said.

The relative risk for death was 45% lower in the Calquence plus obinutuzumab arm, based on an HR of 0.55, 95% CI 0.30-0.99, the company said.

An estimated 90% of patients treated with the Calquence combination were alive at 5 years versus 84% for Calquence alone and 82% for chlorambucil plus obinutuzumab, the company said.

Separately, follow-up data from the ASCEND phase 3 trial showed Calquence demonstrated a sustained PFS benefit at 4 years based on investigator assessment compared with investigator’s choice of rituximab combined with either idelalisib (IdR) or bendamustine (BR) in adults with refractory or relapsed CLL, the company said.

At 42 months, an estimated 62% of patients treated with Calquence were alive and had not progressed by comparison with 19% of patients treated with IdR/BR, the company said.

The median follow-up was 46.5 months for Calquence and 45.3 months for IdR/BR, the company said.

The safety and tolerability of Calquence in the ASCEND and ELEVATE-TN trials were consistent with earlier findings, with no new safety signals identified, the company said.

The results were presented at the 2022 American Society of Clinical Oncology Annual Meeting on June 4, 2022.

“These data from ELEVATE-TN, with nearly 5 years of follow-up, support what I have seen in clinical practice and provide clinicians with further reassurance when prescribing this therapy. Patients with chronic lymphocytic leukemia often remain on therapy for many years, so long-term efficacy and tolerability are critical factors that physicians consider when deciding on a treatment plan,” Jeff P. Sharman, MD, director of research at Willamette Valley Cancer Institute, Medical Director of Hematology Research for the US Oncology Network, and a lead investigator of the ELEVATE-TN trial, said in the statement.

Calquence plus obinutuzumab demonstrated sustained survival benefit in 1st-line chronic lymphocytic leukaemia with 90% of patients surviving five years in ELEVATE-TN trial. AstraZeneca. News release. June 4, 2022. Accessed June 5, 2022. https://www.astrazeneca.com/media-centre/press-releases/2022/calquence-plus-obinutuzumab-demonstrated-sustained-survival-benefit-in-1st-line-chronic-lymphocytic-leukaemia.html

AstraZeneca trial results shows 90% of patients with chronic lymphocytic leukemia surviving for 5 years. 

Calquence Demonstrates Sustained Survival Benefit for CLL

Roche Group’s Genentech subsidiary has announced new 2-year data from its phase 3 studies of Vabysmo (faricimab-svoa) and Susvimo (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant.

These longer-term results, which will be presented at the Angiogenesis, Exudation, and Degeneration 2022 meeting on February 12, 2022, from the Vabysmo YOSEMITE and RHINE studies in diabetic macular edema (DME) and the Susvimo Archway study in wet, or neovascular, age-related macular degeneration (AMD), reinforce the potential to allow for longer times between treatments and fewer eye injections for individuals with these conditions, while still achieving and maintaining vision gains seen with previous standard-of-care injections.

DME and Wet AMD are 2 leading causes of vision loss, together affecting nearly 2 million individuals in the United States, who require treatment with eye injections as often as once a month.

“Results from these 3 studies reinforce the potential of Vabysmo and Susvimo to redefine standards of care and reduce treatment burden for people living with diabetic macular edema and wet AMD,” Levi Garraway, MD, PhD, chief medical officer and head of global product development at Genentech, said in a statement. “These 2 first-of-their-kind treatments are the culmination of over a decade of pioneering research, aiming to better address the needs of people with retinal conditions.”

In the YOSEMITE and RHINE studies, at least 60% of individuals eligible for extended dosing with Vabysmo could be treated every 4 months at 2 years – a 10-percentage-point increase since the primary analysis at 1 year – while achieving non-inferior vision gains versus aflibercept given every 2 months. Furthermore, nearly 80% of individuals eligible for extended dosing with Vabysmo could be treated every 3 months or longer. In the Archway study, Susvimo allowed 95% of individuals to go 6 months between treatments at 2 years – the fourth complete refill-exchange interval – while maintaining vision outcomes that were non-inferior to monthly ranibizumab injections. Across all 3 studies, with longer follow-up, Vabysmo and Susvimo continued to be generally well tolerated, with favorable benefit-risk profiles. Safety will continue to be monitored closely in the post-market setting.

Vabysmo is the first bispecific antibody for the eye approved by the FDA and the only injectable eye medicine approved for treatments from 1 to 4 months apart in the first year following 4 initial monthly loading doses, based on evaluation of the patient’s anatomy and vision outcomes. Vabysmo is designed to block 2 disease pathways linked to several vision-threatening retinal conditions by neutralizing angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). Ang-2 and VEGF-A are thought to contribute to vision loss by destabilizing blood vessels, which may cause new leaky blood vessels to form and increase inflammation. Although additional research continues, inhibition of both pathways has been shown in preclinical studies to have potentially complementary benefits, stabilizing vessels and thereby reducing vessel inflammation and leakage more than inhibition of VEGF-A alone.

Susvimo is the first wet AMD treatment in 15 years to provide an alternative to standard-of-care eye injections. By continuously delivering medicine into the eye through a refillable implant, Susvimo is the only FDA-approved treatment that may help people with wet AMD maintain their vision with as few as 2 treatments per year.

New 2-year data for Genentech’s Vabysmo and Susvimo reinforce potential to maintain vision with fewer treatments for people with two leading causes of vision loss. Genentech. News release. February 10, 2022. Accessed February 11, 2022. https://www.gene.com/media/press-releases/14944/2022-02-10/new-two-year-data-for-genentechs-vabysmo

Genentech has released new 2-year data for individuals with diabetic macular edema and wet age-related macular degeneration.

Vabysmo, Susvimo Help Maintain Vision With Fewer Treatments in Phase 3 Studies

Safety within pharmacies is a priority in the best of times, but it has become essential to ensure that pharmacies and pharmacists do not spread coronavirus disease 2019 (COVID-19) during the pandemic.

To that end, the Pharmacist Moms Group, the largest group of female pharmacists in the United States with more than 31,000 members, set up a special task force that has issued guidelines for pharmacists working in community pharmacies. 

 cover operations, personnel, recommendations for patients, end-of-workday procedures, additional tips, and national resources.

“Pharmacist Moms wanted to help prepare pharmacists and pharmacy technicians who may be exposed and provide them with proper support. We need to be proactive as pharmacists to protect ourselves,” Suzanne Soliman, PharmD, BCMAS, chief academic officer at the Accreditation Council for Medical Affairs and the founder of Pharmacist Moms Group, said in an email interview.

Important safety measures for pharmacy staff members addressed by the guidance include, “washing hands frequently with soap and water for at least 20 seconds, avoiding touching the face, and wearing personal protective equipment such as gloves and masks if available,” task force member Jennifer Gershman, a drug information pharmacist in South Florida, said in an email interview.

“Providing drive-through services and limiting the [number] of patients inside the pharmacy is also important to protect the staff,” she said. “Credit card machines, counter tops, and door handles should also be cleaned frequently.”

Another member of the task force, Hillary Blackburn, PharmD, director of pharmaceutical services at Dispensary of Hope in Nashville, Tennessee, which donates and dispenses medications philanthropically, said that she has been heavily involved in developing the distribution center staff employee wellness screenings for onsite workers and cleaning procedures for them.

Procedures at the distribution center include checking employee temperatures each day, hand-washing and sanitizing, cleaning workstations, surfaces, and other high-touch areas.

There is also a checklist for employees to make sure that they and anyone living in their homes are not experiencing a fever, new cough, or shortness of breath, as well as guidelines for what employees should do if they test positive for COVID-19 or live with someone who has.

“The safety of our employees is of the utmost importance to us,” Blackburn said in an email interview.

Travis Wolff, PharmD, owner of Med-World Pharmacy in Sapulpa, Oklahoma, said in an email interview that his pharmacy is taking similar precautions.

“We have timers set and signature logs, requiring us each to wash our hands for 20 seconds once per hour, as well as disinfect patient care workspaces. If [there is] no visible sickness, we are disinfecting with Lysol/bleach/regular protocol stuff, but if [someone is] visibly sick or [there is] reported exposure to a patent, we clean with a viral germicidal agent with known antiviral activity (currently using Citrus II),” Wolff said.

In terms of direct patient care, the pharmacy’s staff members are offering service via drive-through window and are wearing N95 masks and using gloves when anything is received or given to a patient, including cash, credit and insurance cards, hard-copy prescriptions, and identification, he said.

The pharmacy asks delivery drivers about illness or exposure to illness over the phone and collects payment over the phone, Wolff said. The drivers give exact delivery times to patients and leave medications on their doorstep, watching from their cars to make sure they pick up what is dropped off. These drivers, who have Citrus II spray, gloves, and N95 masks, are not allowed to enter homes or take anything from patients, including cash.

In addition, Wolff said that the state board of pharmacy has mandated that all pharmacy benefit managers accept “CV19” or “COVID-19” for all signatures, so that “we are not sharing ink pens both on deliveries or at the drive-through.”

Med-World is continuing its clinical management programs but has switched over to the Zoom video conferencing service for most consultations and is doing immunizations and point-of-care testing curbside, he said.

The pharmacy has educated all staff members about the likelihood of being an asymptomatic carrier, so they are practicing social distance, including grocery deliveries to their homes.

“We have even offered childcare in the back if anyone needs it, hiring a school aide who otherwise is not going to work anyway,” Wolff said.

He recommends that pharmacies also assess the health status of their employees, including taking their age, disease states, and medication profiles into consideration.

“We have an employee on a specialty medication for psoriasis, who, while otherwise healthy, cannot afford to be exposed. So we have given her some case management duties in an office, not in direct patient care,” Wolff said.

At the end of the day, “our staff are like family,” Wolff added. “It is important being [on] the frontline that we are vigilant in our procedures and make sure our staff are equipped to be successful.”

Guidelines for pharmacists in community pharmacy. Pharmacist Moms. 

pharmacistmomsgroup.com/guidelines-for-pharmacists-in-community-pharmacy/

. March 17, 2020. Accessed March 20, 2020.

Pharmacy Moms Group special task force develops guidelines as precautions are implemented amid the COVID-19 pandemic. 

Pharmacies Step Up COVID-19 Safety Measures

As the novel coronavirus (COVID-19) crisis continues, one key issue for pharmacists, other health care professionals, and patients is the potential for drug shortages in the United States.

There is growing concern because although reserves exist, China experienced a drop-off in drug production during the height of its COVID-19 outbreak, though that is leveling off.

 And India, another big supplier, has also said that it will keep some of the medications it makes on reserve.

“We are now starting to see spot shortages for a few different products, in part due to disease progression around the world, especially across Europe, which is a large producer of drugs,” Soumi Saha, PharmD, JD, senior director of advocacy at Premier Inc in Washington DC, said in an email interview with 

. “Italy, for example, is the (number) 3 producer of active pharmaceutical ingredients behind India and China, so we’re keeping a close eye on the availability of raw ingredients from that region as part of our ongoing risk assessments.”

Premier is a health care improvement company that unites an alliance of approximately 4000 health systems and hospitals and more than 175,000 other organizations and providers. Saha said that Premier is also seeing an increase in the purchase of drugs that are expected to become frontline therapies for COVID-19.

For example, she said, “South Korea recently reported that certain anti-malarial drugs have positive outcomes in COVID-19 patients, and within 24 hours we saw a dramatic uptick in the purchasing of those drugs across the country.”

In terms of drug reserves, Premier is working with manufacturers to understand how much product is available to wholesalers, how much is in warehouses, or “how much could be on a barge coming across the Indian Ocean,” Saha said.

“We know that manufacturers of products for Premier’s drug shortage programs, including ProvideGx, have safety stock, and we are in discussions with suppliers, particularly for products that are in high-demand categories right now, such as metered dose inhalers and cholorquine, about ramping up production and ensuring adequate allocations in the supply chain,” Saha said.

Meanwhile, the FDA has announced a drug shortage caused by the COVID-19 outbreak but has not identified the drug or the country where it is made, in an effort to prevent hoarding and panic.

However, the agency “should be sharing this information with private sector partners to help address the situation and ensure additional supply is available as soon as possible. At organizations such as Premier, if we know which drugs are in potential shortage, we can leverage our ProvideGx drug-shortage subsidiary to incentivize manufacturers to enter the marketplace and manufacture the drug,” Saha said.

Receiving such information would help Premier to help prevent a drug shortage before it becomes widespread, she said, adding that the company is in discussions with the FDA to “release this critical information to us soon.”

pharmacists think that this is a good time to show their value

“We can help with therapeutic interchange while navigating the patient’s formulary better than anyone on the medical team. We should be proactive and jump in when we can, never contacting the physician without a solution to the identified shortage,” Travis Wolff, PharmD, owner of Med-World Pharmacy in Sapulpa, Oklahoma, said in an email interview with 

Although some pharmacies are marketing 90-day supplies to limit the number of patient visits, he said that pharmacists should discourage that practice.

“If an otherwise healthy patient gets new 90-day supplies, we will end up like toilet paper with empty shelves,” Wolff said. “We should screen and only grant 90 days or early fills to the most at-risk patients.”

Tara Fink, PharmD, pharmacy clinical services manager at Walmart Health & Wellness in Fort Worth, Texas, said in an email interview with 

that “we have been managing significant medication backorders, shortages, and recalls on a variety of medications for the last couple of years, more so than ever before” in the retail setting.

“COVID-19 is creating a paradigm shift, but I am confident that we will find a way to take care of our patients should a shortage arise, as we have always done,” she said. “I’m very proud of my colleagues and encouraged by the brave pharmacists stepping up to meet all the new challenges that are coming our way.” 

Another concern is a shortage of medical supplies, such as personal protective equipment (PPE). Premier’s surveys of supply inventories in the acute space and at senior living facilities show that some providers are running low on PPE, such as masks.

Many have initiated conservation strategies, and Premier is recommending that all providers immediately implement these strategies until manufacturing of these products ramps up, Saha said. Premier has compiled a one-page document of best practices during extended use of PPE, which it has distributed to its members, she said.

Saha remains optimistic about the drug supply, however, because she says that the pharmacy profession is accustomed to dealing with shortages.

“We’ve had over 100 drugs on the FDA shortage list and 200 on the [American Society of Health-System Pharmacists] shortage list for years. While pharmacy manufacturing is not resilient, the practice of pharmacy has become,” Saha said.

“Pharmacists are adept at finding alternatives when the ideal drug is not available,” she said. “If anyone knows how to handle shortages, it’s pharmacy.”

Lupkin S. How coronavirus is affecting the U.S. pharmaceutical supply. NPR. March 12, 2020. 

npr.org/sections/health-shots/2020/03/12/814623335/how-coronavirus-is-affecting-the-u-s-pharmaceutical-supply

Goel V. As coronavirus disrupts factories, India curbs exports of key drugs. The New York Times. March 3, 2020. 

nytimes.com/2020/03/03/business/coronavirus-india-drugs.html

FDA. Coronavirus (COVID-19) supply chain update. 

fda.gov/news-events/press-announcements/coronavirus-covid-19-supply-chain-update

. Published February 27, 2020. Accessed March 19, 2020.

Premier Inc. survey finds 86 percent of health systems are concerned about personal protective equipment shortages due to coronavirus [news release]. Charlotte, NC; March 2, 2020: Premier Inc website. 

premierinc.com/newsroom/press-releases/premier-inc-survey-finds-86-percent-of-health-systems-are-concerned-about-personal-protective-equipment-shortages-due-to-coronavirus

Premier Inc. survey: more than two-thirds of senior living facilities say they can’t access personal protective equipment needed for COVID-19 containment plans. [news release]. Charlotte, NC; March 16, 2020: Premier Inc website. 

premierinc.com/newsroom/press-releases/premier-inc-survey-more-than-two-thirds-of-senior-living-facilities-say-they-cant-access-personal-protective-equipment-needed-for-covid-19-containment-plans

COVID-19 and PPE conservation. Premier Inc website. 

premierinc.com/newsroom/education/covid-19-ppe-conservation

. Published March 18, 2020. Accessed March 19, 2020.

As the COVID-19 pandemic continues, a key issue for pharmacists, other health care professionals, and patients is the potential for disruptions in the US medication supply chain.
 

Drug Shortage Concerns Are Top of Mind Amid COVID-19 Outbreak

Pharmacists should document all that they do to help transform their practices and attract payers.

That was the takeaway from the session, “Care Planning: The Key to Thriving and Surviving” at the National Community Pharmacists Association (NCPA) 2019 Annual Convention in San Diego, California, on Monday, October 28.

Pharmacy system vendors are making care planning and documentation easier than ever before, according to Mark McCurdy, RPh, owner of Mark’s Pharmacy in Cambridge, Nebraska, who told attendees that he is no different than they are, except that his pharmacy decided to adopt a community wellness mentality 4 years ago and start documenting patient interactions.

He provided an overview of how care planning can increase pharmacy profits through efficiencies and through new revenue from payers that value what pharmacists do for patients, if they see the documentation of what has been done.

McCurdy focused on 3 things during the session: the elements of a care plan to document interactions with patients; strategies for implementing planning into a pharmacy’s workflow; and identifying the types of interventions that can be documented in a care plan.

“Who are you telling that you’re providing this patient care? Are you able to prove it?” McCurdy asked.

“You need to be able to get credit for what you’re doing” on the medical side, he said.

The payers want to know what value they get from pharmacists providing patient care.

“If you don’t document it, it didn’t happen. You have to put down in code how you’re taking care of these people,” McCurdy said.

Pharmacists have been engaging in uncompensated care for a long time, so it is time to document that the services they offer to patients are cheaper than them visiting a doctor or emergency department, he said.

“We’re very convenient for patients,” McCurdy said. “We’re very available for patients.”

It is key to get buy-in from everyone who works in the pharmacy.

“You need to engage everyone in your pharmacy with care planning,” McCurdy told the audience. “This is going to take everyone in your pharmacy to make this happen.”

McCurdy advised that pharmacists use systematized nomenclature of medicine — clinical terms (SNOMED) codes. SNOMED is a vocabulary of clinical terminology that is used by health care providers for the electronic exchange of clinical health information.

“If you’re recording a blood pressure, there’s a code for that. If you’re giving an immunization, there are codes for that.” McCurdy said.

In terms of care planning, it takes time to set up patients, but it is worth it, said McCurdy, who added that pharmacists might want to use employees, such as pharmacy technicians, to do some of this work.

McCurdy recommends that pharmacies use cheat sheets, codes, and screen shots of care plans to move forward.

He also says that pharmacies can look into automation of their processes

“There are vendors that will help manage this,” McCurdy said, though some solutions can also be managed in house.

Some types of care plan activities that can be documented are disease and medication education, dosing and dosing changes, and vaccinations.

“You can no longer rely on dispensing alone,” he said.

McCurdy M. Care Planning: The Key to Thriving and Surviving. Presented at: National Community Pharmacists Association (NCPA) 2019 Annual Convention; San Diego, California; October 28, 2019.

Care planning can increase pharmacy profits through efficiencies and through new revenue from payers that value what pharmacists do for patients, if they see the documentation of what has been done.