Darlene Dobkowski, MA

The Food and Drug Administration (FDA) approved Keytruda (pembrolizumab) for use with trastuzumab, fluoropyrimidine-and platinum-containing chemotherapy for first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma.

This accelerated approval was based on an analysis of 264 patients with HER2-positive advanced gastric or GEJ adenocarcinoma from the ongoing KEYNOTE-811 trial, according to a release from the FDA. In this trial, patients were not previously treated with systemic therapy for metastatic disease. Patients were assigned either 200 milligrams of Keytruda or placebo every three weeks. Both groups also received trastuzumab and either Xeloda (capecitabine) plus Eloxatin (oxaliplatin) or fluorouracil plus cisplatin.

The overall response rate (or the percentage of patients with partial or complete response to a therapy) was 74% in patients assigned Keytruda compared with 52% in those assigned placebo. In addition, Patients in the Keytruda group had a longer median duration of response compared with those in the placebo group (10.6 months versus 9.5 months. The side effect profile in patients treated with Keytruda was consistent with what has already been established with this particular drug, according to the release.

The recommended dose of Keytruda for adults with locally advanced unresectable or metastatic HER2-positive gastric or GEJ adenocarcinoma, in addition to trastuzumab and chemotherapy, is either 200 milligrams every three weeks or 400 milligrams every six weeks.

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Based on findings from the KEYNOTE-811 trial, the FDA approved Keytruda for the treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma in combination with trastuzumab and chemotherapy.

FDA Approves Keytruda for Use With Trastuzumab and Chemotherapy for Subtypes of Stomach Cancer

Patients with relapsed/refractory mantle cell lymphoma treated with Tecartus (brexucabtagene autoleucel) had significant and durable responses and a reduction in side effects, according to long-term follow-up data from the phase 2 ZUMA-2 trial presented at a virtual meeting.

At a median follow-up of 17.5 months, the objective response rate (or the rate of a measurable response to the treatment) was 92%, the complete response rate (or the disappearance of cancer as a response to treatment) was 67% and the partial response rate (a decrease in tumor size or the amount of cancer in the body as a response to treatment) was 25%. The stable disease and progressive disease rates were both 3%.

Twenty-nine of 60 evaluable patients (48%) remain in ongoing responses, and 28 of 40 patients who achieved a complete response (70%) remain in response. The first 28 patients treated had a median follow-up of 32.3 months; 39% of patients remain in remission without additional treatment.

In all enrolled patients (74 patients), the objective response rate was 84%, and the complete response rate was 59%.

“The ZUMA-2 study continues to show substantial and durable clinical benefit and a manageable safety profile with (Tecartus) therapy in patients with relapsed/refractory (mantle cell lymphoma) with extended follow-up,” said Dr. Michael L. Wang, professor in the Department of Lymphoma and Myeloma at The University of Texas MD Anderson Cancer Center, in a presentation of the data.

Poor outcomes are associated with patients with relapsed/refractory mantle cell lymphoma who progress on BTK inhibitors. These patients typically derive an objective response rate of 25% to 42% and an overall survival of six to 10 months with salvage therapy.

The ZUMA-2 trial evaluated Tecartus in patients with relapsed/refractory mantle cell lymphoma who received one to five prior lines of therapy including a BTK inhibitor. In the primary efficacy analysis (60 patients), the objective response rate was 93% and the complete response rate was 67% at a median follow-up of 12.3 months.

Objective response rate served as the major focus of the trial, with additional areas of focus including duration of response, progression-free survival (time during and after treatment when a patient lives with cancer without disease progression), overall survival (time from treatment initiation that a patient is still alive), side effects and levels of CAR-T cells in the blood and cytokines in serum.

Additional results showed that the median duration of response, progression-free survival and overall survival had not been reached at the median follow-up, meaning that researchers could not calculate this information since more than half of patients in the study were alive. At 15 months, duration of response was 59%, progression-free survival was 59% and overall survival was 76%.

Among all treated patients (68 patients), the side effects that were present for three months or greater post-infusion included anemia, very low counts of a white blood cell called neutrophils, low platelet levels, white blood cell count decrease, fatigue, pneumonia, cough, low antibody counts that increases the risk for infection, and upper respiratory tract infection. Some of these side effects were present for six months or more post-infusion.

Side effects that occurred between the last data cutoff and the current data cutoff included very low neutrophil counts, infection, anemia, a neurologic event and low platelet levels.

“The pharmacological findings in ZUMA-2 point to different mechanisms responsible for primary and secondary treatment failure in relapsed/refractory (mantle cell lymphoma),” concluded Wang.

Factors including progression-free survival, duration of response and overall survival were promising at 15 months in patients with relapsed/refractory mantle cell lymphoma.

Tecartus May Contribute to Long-Term Responses in Relapsed/Refractory Mantle Cell Lymphoma

CURE Media Group recognized Maria Lim, B.S.N., RN, OCN, BMTCN, as the winner of its 2021 Extraordinary Healer® Award for Oncology Nursing, which honors the expertise, compassion and helpfulness often seen by nurses in the cancer community.

In addition, Jennifer E. Giovanni, Ph.D., MSN, MPH, RN, received the Finest Hour Award, which recognizes the selfless achievements of a nurse caring for patients during the COVID-19 pandemic.

Essays were submitted by colleagues, patients and family members that identified Lim, two finalists and nearly 100 other Extraordinary Healer® nominees, all detailing the noble acts of oncology nurses, from providing a shoulder to cry on, a blanket to keep warm to even making accommodations above and beyond their call of duty to make patients’ experience during cancer treatment a little more tolerable. Giovanni was also one of over 20 nominations for the Finest Hour Award. Both awards were given April 29 during a virtual celebration held in conjunction with the 46th Annual ONS Congress.

Lim, a nurse since 1993 in the Philippines moved to the United States, where she now serves as a hematology/oncology/infusion clinic nurse at the Captain James A. Lovell Federal Health Care Center in North Chicago, Illinois, was nominated by one of her patients, who considered her the modern-day “angel of the battlefield.” Lim aims to be not only a nurse but a support system for all of her patients, some of whom have their own battles with post-traumatic stress disorder, for example, beyond cancer.

Giovanni, who was previously a travel nurse, started her life of serving others in 1995 when volunteering with the Peace Corps. Since then, she has worked for several agencies including the Centers for Disease Control and Prevention, the U.S. Air Force and, most recently, in New York and New Jersey as a crisis response critical care nurse in areas severely affected by the COVID-19 pandemic.

Finalists for the Extraordinary Healer Award were Jessica Ellison, M.S.N., B.A., RN, a transplant coordinator at Rush University Medical Center in Chicago, and Katherine Gacek, B.S.N., RN, OCN, a nurse navigator from the University of Chicago Medicine.

Michael J. Hennessy, Jr., president of MJH Life Sciences, the parent company of CURE Media Group, mentioned how he experienced the impact oncology nurses have directly with his mother, Patti Hennessy, who died early January 2020 after living with breast and ovarian cancers for nine years. “The nominations come from your patients, your coworkers, loved ones, and it's just utterly remarkable,” he said. “After reading through the different essays that we received and seeing firsthand through the care that my mother received during her battles with cancer, oncology nurses are the most selfless, caring and truly inspiring individuals that you can be around. The way that you're all able to comfort patients in what is probably the most traumatic time of their lives is inspiring.”

Keynote speaker Sterling K. Brown, who is known for his role as Randall Pearson on the TV show “This Is Us,” among others, delved deeper into his role as a cancer advocate, which stemmed from his experience of losing his uncle to cancer. During his keynote lecture, he showed his appreciation of oncology nurses, who often lean into the stressful, emotional situation rather than step away from it.

“There's a level of investment that nurses have in their patients, necessarily, in order to be a good one, I believe,” he said. “As a family member of people who have transitioned and have recovered, I'm so full of gratitude for what you do. My constitution is a little bit different, but at times in which I feel as if I can lean in and there's times in which I have to step away, but you guys are always leaning in, always doing the work that's not pretty, it's not glamorous, but is essential and necessary. From the bottom of my heart, … to all I say thank you.”

Lim was nominated by her patient, Bradford Evans, whom she has known for almost five years this-coming August. In his interview, Evans said he can’t imagine working with any other attending nurse and calls her the “helping hands” of the infusion unit.

“Myself or any of the other patients, we don’t know what tomorrow is going to hold,” Evans said. “It’s by the grace of God that we’re here. Ms. Maria, through her helping hand, she’s the emissary of God, to keep us alive and keep us kicking. I will forever be indebted to her for her kindness, her professionalism. She listens to us, and not only me, but she listens to all the patients.”

Evans mentioned Lim had an important role in his life the moment he received his cancer diagnosis. “As soon as he said, ‘(I’m referring you to) oncology, my world stopped, and she brought the world back around,” he said.

Lim aims to make chemotherapy a “somewhat enjoyable event,” Evans said, by cheering patients up, greeting them with a warm smile and even placing patients near each other so they can share stories about their active duty days.

Lim has always recognized the importance of patients with cancer, especially those who are on active duty or veterans. “When they’re diagnosed, it’s really like, OK, they’re veterans, they have this experience,” she said. “Some of them have PTSD, they have psych issues and all of that. And then now they’re diagnosed with cancer. It’s like another battle for them.”

Giovanni was nominated by her aunt, Pam Malone, RN, APRN, who quoted a previous writing of Giovanni’s in her nominating essay and interview. Malone mentioned how from the start, Giovanni’s life has been one of serving others.

“Jennifer is someone who has done in her life all the things I wish I could have done,” Malone said. “She has from the get-go — even before she became a nurse — hers was a life of service and trying to help others, starting out in the Peace Corps and progressing from there. Most recently with (COVID-19), she has been on those frontlines on more than one occasion. And I don't know how she does it, but she did and her experiences really meant a lot to her.”

During the interview, Giovanni detailed a time she was there for a patient with stage 4 lung cancer with metastases to his brain and liver before he was intubated, which required “one final call” with his wife and children, according to the resident. With an iPad in hand, Giovanni virtually brought his family to his bedside. His family comforted him with “don’t worry” and “we’ll see you in a little bit,” although the patient understood his outcome. The patient’s son came to visit the day before he died.

“I was in there cleaning the room and doing those herculean nursing tasks that we're all to do somehow in 14 hours,” Giovanni said. “The son was outside the room, and I just thought what it must be like to stand there and look at your father intubated, clearly in a bad way, and not be able to touch (him). … That was a heavy day, but that was also a heavy phone call, but also one that I walked away with gratitude because I was that presence at that sacred space.”

Giovanni took the opportunity to thank everyone for the award not only from herself, but also on behalf of all nurses on the frontlines. “There's something very special about the nurses that came forward to take care of patients with severe COVID-19, and also those that keep doing it day after day after day,” she said. “The trauma of it is profound, and it doesn't come upon (a nurse) until one steps away, and then it is overwhelming. I worry about the nurses that are out there doing this day in and day out. They are the true heroes.”

Ellison was nominated by Dr. Paul Kent from Rush University Medical Center, who credits Ellison for establishing their institution as a national leader for patients with fibrolamellar carcinoma, a type of liver cancer that affects you, healthy children and adolescents.”

“People come (to Rush University Medical Center) because they want to have a team that’s going to take this rare disease really seriously and really do a deep dive,” Kent said during the interview. “We have two of the best surgeons you could ever want, the best interventional radiologist you ever want, but not a single part of this, not from day one and not until today would have been possible without Jessica.”

Kent added that patients with fibrolamellar carcinoma represent a unique population especially since they are young, some of whom are diagnosed in their teenage years and continue treatment into early adulthood. This leads to various questions such as whether patients should be seen by a pediatrician or an adult doctor, among other concerns. “It’s really quite a diverse and confusing group, but the bottom line is these are all healthy patients who deserve a chance. Without Jessica, they wouldn’t have this chance.”

Ellison mentioned that she was at first caught off-guard when receiving a phone call that she was a finalist for the Extraordinary Healer award, but then realized that Kent must have nominated her for it. “It has been a lot of work,” she said about establishing the program at her institution. “There’s been a lot of … tears from my eyes, tears from the patient’s eyes. It’s been a long journey for all of us, but in the end, I know that some of the work or all of the work that I have done has helped several patients, families and their caregivers.

Gacek was nominated by Rose Conti, M.S.N., RN, CNM, who detailed in her essay and interview about a time the nurse navigator made a storyboard to detail every treatment step for a nonverbal patient with autism who was being treated for Hodgkin lymphoma. The patient, who at first had disruptive behavior because he did not understand the severity of disease, was put at ease through Gacek’s efforts.

“She does this for all of her patients, but this patient in particular was something that stood out,” Conti said in the interview. “She really takes the time to make them feel comfortable. And this one was a very, very, very difficult patient for not only Catherine, but the nurses that were caring for him in the infusion suite. Her extra steps to care for this patient and make him feel comfortable did just so — it was a world of difference of what we saw in his actions and how he actually took his care while he was with us.”

Gacek added some insight into that particular situation, which she practices with every patient she cares for.

“I could not believe that it works so well,” Gacek said. “And I just feel like I had such a small piece of the puzzle to get this this done, but I think it just showed that sometimes we have to think outside of the box. That was one of those cases and nurses are doing all these things all the time. We're being very inventive, and it's not always straightforward, but we just have to find a way to get things done.”

Gacek mentioned how recognition, such as being an Extraordinary Healer® Award finalist, was a humbling experience.

“I'm just so, so thankful that nurses are being recognized because there are times that we are the unsung heroes,” Gacek said. “Especially in oncology, we wear so many hats and along with helping patients get through their treatment that means so many things. That could mean helping with side effects or helping someone get to and from their appointments or helping a mom explain to their school-aged child what does it mean to go through chemotherapy, and what is that going to mean for them. It's just such a rewarding experience already. It's just so appreciated to get recognized.”

Kristie L. Kahl, vice president of content at MJH Life Sciences, the parent company of CURE Media Group, hosted the virtual event and took the opportunity to thank the nurses and doctors who have worked tirelessly throughout the COVID-19 pandemic.

“I would like to this opportunity to thank all the front-line nurses and doctors who have not skipped a beat,” she said. “Over the last year-plus, you’ve put your health and the health of your family members at risk, all to ensure that your patients can continue their treatments, and now get vaccinated against this virus that has turned our worlds upside down. Your dedication has not gone unnoticed. Your patients thank you, we thank you and hope everyone continues to stay safe.”

The event was sponsored by Bristol Myers Squibb and Janssen Oncology. Jana Low, regional business director in cardiovascular at Bristol Myers Squibb, experienced the selflessness of oncology nurses when she herself was diagnosed with melanoma.

“Each of you are so blessed to touch so many patients’ lives, and each of you are truly so courageous,” Low said. “On behalf of everyone at Bristol Myers Squibb, I thank you for your compassion, your dedication and for being there every day for each of us. No matter what nurse hat you're wearing, you are critical in our fight. Each battle is unique to that (patient with cancer) and their family, and through your work, continue giving patients and their loved ones the strength when they need it most.”

Pearl Pugh, vice president of sales and marketing of hematology at Janssen Oncology, mentioned that the COVID-19 pandemic has been a challenge for everyone, especially front-line workers, but they continued to dedicate their lives to others despite the circumstances.

“You continue to make a difference for patients in so many other ways,” Pugh said. “You educate your patients, you advocate for them, you wipe their tears, you celebrate successes and guide patients and families through the most difficult times of their lives. And during the pandemic, when patients have not been able to have their loved ones or caregivers by their sides in the hospital or at the treatment clinics, you've helped to fill the void by offering hope and support.”

Laura Leonetti, director of marketing of multiple myeloma at Janssen Oncology, echoed Pugh’s admiration of front-line workers during the COVID-19 pandemic.

“The COVID-19 pandemic has put the role of front-line health care workers, including nurses like yourselves, in the well-deserved spotlight,” Leonetti said. “For over a year now, you have overcome tremendous challenges and worked tirelessly during an unprecedented health care crisis. The world has seen firsthand the skill, determination and heart it takes to serve as a nurse on the frontlines. You are truly bright and brave heroes not only to cancer patients, but to all of us.”

now accepting nominations for the 2022 Extraordinary Healer® Award for Oncology Nursing

To view the entire 2021 Extraordinary Healer® Award for Oncology Nursing virtual presentation, click 

CURE Media Group also recognized Jennifer E. Giovanni, Ph.D., MSN, MPH, RN, as winner of the Finest Hour Award, which highlights the dedication and selflessness exhibited in front-line workers during the COVID-19 pandemic.

Maria Lim, B.S.N., RN, OCN, BMTCN Wins CURE®’s 2021 Extraordinary Healer® Award for Oncology Nursing

Women with previously treated recurrent or metastatic cervical cancer treated with the novel antibody-drug conjugate tisotumab vedotin had a durable antitumor activity with a manageable safety profile, according to a study published in 

“Women with recurrent or metastatic cervical cancer have a high unmet clinical need because this disease is incurable and lacks a standard of care after progression on first-line treatment,” the study authors wrote. “The multiple mechanisms of action of tisotumab vedotin, including (monomethyl auristatin E)-directed cytotoxicity, bystander effect and immunogenic effects, might contribute to the promising efficacy observed in our study.”

To assess the activity and safety of tisotumab vedotin in this specific patient population, researchers analyzed data from 101 women (median age, 50 years) with previously treated recurrent or metastatic cervical cancer. All patients were treated with 2 mg/kg (a maximum of 200 mg) of tisotumab vedotin intravenously once every three weeks until unacceptable toxicity or disease progression. Researchers were interested in the confirmed objective response rate, defined as the percentage of patients with partial and complete responses to the treatment.

Follow-up was conducted for a median of 10 months. During the study, the median treatment duration was 4.2 months, with a median number of doses received of six.

The confirmed objective response rate for all patients was 24%, which included 17% with partial responses and 7% with complete responses.

Some of the most common side effects related to treatment with tisotumab vedotin included nosebleed (30%), patchy hair loss (38%), fatigue (26%), pink eye (26%) and dry eye (23%). Severe or worse side effects related to the treatment occurred in 28% of patients and included fatigue (2%), inflammation and ulcers of the cornea (2%), low neutrophil bloods counts (3%) and numbness, pain and weakness in the hands and feet from nerve damage (2%). Serious side effects from the treatment were reported by 13% of patients and included fever (2%) and numbness or weakness in the fingers and feet (2%).

Researchers considered one death from septic shock related to treatment with tisotumab vedotin. There were also three deaths unrelated to the treatment: one from an obstruction in a part of the bowel preventing it from moving waste from the body and two from unknown causes.

“Taken together with a disease control rate of 72%, these data emphasize clinical improvement in a patient population in which rapid response and reduction in tumor burden are crucial for controlling rapidly progressing disease,” the study authors wrote.

Treatment with tisotumab vedotin, a novel antibody-drug conjugate, in women with recurrent or metastatic cervical cancer, led to an objective response rate of 24% with a manageable safety profile.

Darlene Dobkowski, MA

FDA Approves Keytruda for Use With Trastuzumab and Chemotherapy for Subtypes of Stomach Cancer

Tecartus May Contribute to Long-Term Responses in Relapsed/Refractory Mantle Cell Lymphoma

Maria Lim, B.S.N., RN, OCN, BMTCN Wins CURE®’s 2021 Extraordinary Healer® Award for Oncology Nursing

Novel Therapy May Address ‘High Unmet Clinical Need’ in Recurrent/Metastatic Cervical Cancer

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