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Adding E-602 to cemiplimab demonstrated anti-tumor effects in patients PD-L1–resistant solid cancers. 

Novel Drug Combo Is Promising for PD-L1-Resistant Solid Cancers

Mitazalimab combined with mFOLFIRINOX led to responses and survival benefits in patients with metastatic pancreatic ductal adenocarcinoma. 

Mitazalimab Plus mFOLFIRINOX Improves Survival in Pancreatic Cancer

The novel drug SHR-A1921 was safe and efficacious in patients with platinum-resistant ovarian cancer, according to phase 1 data. 

Novel ADC Shows Promise in Platinum-Resistant Ovarian Cancer

Docetaxel was associated with lower rates of peripheral neuropathy compared with paclitaxel for Black patients with breast cancer. 

Chemo Should be Tailored to Decrease Neuropathy in Black Patients

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The combination of onvansertib plus FOLFIRI/bevacizumab showed promise among patients with KRAS-mutated metastatic colorectal cancer.

Onvansertib Combo Appears Efficacious in KRAS+ Metastatic Colorectal Cancer

Following a phase 1b trial, the potent and selective dual inhibitor of IRAK1 and IRAK4 received fast track designation for the treatment of patients with lower-risk myelodysplastic syndrome.

FDA Grants Fast Track Designation to R289 for Lower-Risk MDS

According to the American Lung Association, biomarker testing gaps and low screening rates continue to hinder lung cancer survival; however, rates have improved in the last 5 years regardless.

Lung Cancer Survival Improves, But Gaps in Biomarker Testing Remain

Belantamab Mafodotin Combos Get BLA for Myeloma Treatment

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In the April 2024 issue of Oncology Nursing News, stories focus on bladder-preserving treatment options in bladder cancer, recent FDA approvals, conference news, and embracing vicarious resilience.

The Importance of Quality of Life in Bladder Cancer

No system can properly flourish without constant efforts to diversify, and the nursing field is no exception.

Questions of Accessibility and Inclusion Continue to Draw Attention in Oncology Nursing

The COVID-19 pandemic has lasted longer than most of us predicted, and extra demands and strain have been placed upon the shoulders of all those who work in health care—particularly nurses

A Call for Resilience and Rest for the Oncology Nurse

Glofitamab-gxbm is a CD20×CD3 T-cell engaging bispecific antibody approved for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (LBCL) not otherwise specified or LBCL arising from follicular lymphoma after 2 or more lines of systemic therapy. Glofitamab-gxbm received accelerated approval on June 15, 2023, based on response rate and durability of response in the phase 1/2 NP30179 study (NCT03075696). Continued approval for this indication is contingent upon verification of clinical benefit in a confirmatory trial.

Accelerated approval was based on the positive results from the phase 1/2 NP30179 study where glofitamab-gxbm was given as a fixed course to 132 patients. Fifty-six percent of patients treated with glofitamab-gxbm achieved a response, with a median duration of response of 18.4 months. Of those who achieved a response, 68.5% continued to respond at 9 months; 43% of those treated with glofitamab-gxbm achieved a complete response (remission).

Glofitamab-gxbm is a CD20×CD3 T-cell engaging bispecific antibody with a 2:1 structural format designed to target 1 region that binds to CD3 protein on the surface of T cells (an immune cell) and 2 regions that bind to CD20, a protein on the surface of B cells. The B cells are either healthy or cancerous. The dual-binding activities activate and redirect a patient’s T cells to engage and eliminate the targeted B cells by releasing cancer cell–killing proteins from the T cells. During this process, healthy B cells can also be harmed.

Glofitamab-gxbm is a fixed-duration intravenous infusion. It must be administered through a dedicated infusion line that includes a 0.2-μm in-line filter. It is administered for 13 infusions (a maximum of 12 cycles) or until disease progression or unacceptable toxicity. The duration of infusion varies. Glofitamab-gxbm is administered over 4 hours for cycles 1 and 2 and over 2 hours for cycles 3 to 12. Treatment is completed in approximately 8.5 months.

Day 1 of cycle 1 consists of a single 1000-mg pretreatment dose of obinutuzumab, which may decrease the adverse effects of glofitamab-gxbm. On day 8 of cycle 1, patients receive a 2.5-mg glofitamab-gxbm step-up dose. On day 15 of cycle 1, patients receive a 10-mg glofitamab-gxbm step-up dose. Cycles 2 to 12 are 21-day cycles, with a full 30-mg glofitamab-gxbm dose on day 1. For all cycles, patients are premedicated on the day of infusion with a corticosteroid, an antipyretic, and an antihistamine to reduce the risk of cytokine release syndrome (CRS) and infusion-related reactions.

Glofitamab-gxbm has a boxed warning for CRS, which can be serious and fatal. CRS occurred in 70% of patients in clinical trial findings. In those patients, 35% of cases occurred after the 10-mg dose, 29% after the initial 30-mg targeted dose, and 2.8% after subsequent doses. Patients presenting with signs and symptoms of CRS should be evaluated for potential hospital admission and care managed per institutional guidelines.

Immune effector cell–associated neurotoxicity syndrome (ICANS) was also observed. Cases of any-grade ICANS occurred in 4.8% of patients. Of those patients, grade 3 or higher ICANS occurred in 2.1% of patients. Patients should be monitored for signs and symptoms of neurotoxicity, provided supportive therapy if needed, and instructed to refrain from hazardous activities such as driving a car. Glofitamab-gxbm should be held or discontinued completely based on CRS/ICANS severity.

This drug may be associated with an elevated risk for tumor lysis syndrome in some patients. Patients at risk should be monitored for clinical presentation of tumor lysis—electrolytes, uric acid, and renal function—as clinically indicated.

Tumor flare is another serious adverse effect. This manifests as localized pain and swelling at the sites of lymphoma regions and/or dyspnea from new pleural effusions. Tumor flare was reported in 12% of clinical trial patients; 2.8% of cases were characterized as grade 3. Patients with bulky tumors or disease close to their airway or vital organs should be monitored closely during initial treatment and treated as necessary. Glofitamab-gxbm should be held until tumor flare resolves. Other common adverse effects include rash, fatigue, laboratory test abnormalities, and infection.

What to Inform Patients About to Start Treatment

Educate patients regarding the boxed warning and risk for CRS and ICANS. The most common symptoms of CRS are fever, tachycardia, hypotension, chills, and hypoxia. The most common symptoms of ICANS are headache, peripheral neuropathy, dizziness, and change in mental status. Patients should be informed to alert their care team at the earliest signs of CRS/ICANS. Clear pathways, including clear operational workflows, for the management of CRS and ICANS should be established at treating facilities, and care teams must be educated to provide streamlined, high-quality patient care. Care teams receiving patient symptom–related phone calls should be educated on the workflows established for proper patient referral and care escalation.

Advice for Nurses Who Administer This Agent

It is important to note the median time of onset for CRS in findings from clinical trials was 14 hours (range, 5-74) and that CRS resolved in 98% of patients, with a median duration of 2 days (range, 1-14). Ensure patients are given a wallet card regarding their risk of CRS while receiving this medication. Although patients should be instructed to stay close to their treatment facility for 24 hours after treatment, there is a chance a patient could present to an outside hospital. Patients presenting to an outside facility or emergency department must be educated to show their wallet card to the outside care team, as their treatment may need to be managed differently. Patients with signs and symptoms of CRS/ICANS must be rapidly evaluated by the care team. Consider administering anti–IL-6 therapy for grade 1 or higher CRS that is unresponsive to supportive therapy. Glofitamab-gxbm should only be administered in a facility equipped to manage CRS and ICANS.

Glofitamab-gxbm should be administered by chemotherapy/biotherapy/immunotherapy-credentialed registered nurses with immediate access to medical support and supportive medications for the management of CRS.

Columvi. Prescribing information. Genentech; 2024. Accessed August 15, 2024. https://www.columvi-hcp.com/

RX Road Map: Glofitamab-gxbm (Columvi)

The FDA approved the PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test as a companion diagnostic for HER2-positive status in patients with biliary tract cancer. The test will identify patients who are eligible for treatment with zanidatamab-hrii (Ziihera).

the FDA granted accelerated approval to the bispecific antibody zanidatamab

 for the treatment of adult patients with previously treated, unresectable or metastatic HER2-positive (immunohistochemistry [IHC] 3+) biliary tract cancer, as detected by an FDA-approved test.

“This test is a step forward in furthering access to personalized medicine,” Jill German, head of the Pathology Lab at Roche Diagnostics, stated in a news release.1 “The prognosis for patients diagnosed with biliary tract cancer is poor, as very few treatment options exist. Now, these patients have access to the first standardized test that could make them eligible for targeted therapy, potentially improving clinical outcomes.”

The FDA approval of zanidatamab was backed by findings from the phase 2b HERIZON-BTC-01 trial (NCT04466891), which enrolled 87 patients with 

-amplified, locally advanced unresectable or metastatic biliary tract cancer, including gallbladder cancer and intra-/extra-hepatic cholangiocarcinoma, who had received prior gemcitabine-containing therapy.2 Patients were excluded if they had received prior HER2-targeted therapy. All patients needed to have centrally confirmed HER2 status on tissue samples.

Patients received intravenous zanidatamab at 20 mg/kg every 2 weeks. Confirmed overall response rate (cORR) by independent central review served as the primary end point. Key secondary end points included duration of response (DOR), disease control rate (DCR), progression-free survival, overall survival (OS), and safety.

The data that supported the approval showed that patients with HER2 IHC 3+ biliary tract cancer who received the bispecific antibody (n = 62) achieved an ORR of 52% (95% CI, 39%-65%) and an estimated median DOR of 14.9 months (95% CI, 7.4-not evaluable).

Long-term follow-up data presented at the 

 showed that at a median follow-up of 22 months (range, 16-34) and a data cutoff date of July 28, 2023, the cORR and DCR were maintained from the primary analysis in patients with HER2-positive disease, at 41.3% and 68.8%, respectively.3 One additional patient had achieved a complete response. A preplanned subgroup analysis of cORR by HER2 expression demonstrated cORRs in both the IHC 3+ and IHC 2+ cohorts at 51.6% and 5.6%, respectively.

The median DOR increased to 14.9 months (95% CI, 7.4-not reached) from the primary analysis. The median OS was 15.5 months (95% CI, 10.4-18.5). The median OS in the IHC 3+ and IHC 2+ cohorts was 18.1 months (95% CI, 12.2-23.2) and 5.2 months (3.1-10.2), respectively. The 12-month OS rate was 56.2% (95% CI, 44.3%-66.5%) in the HER2-positive population; this rate was 65.0% (95% CI, 51.6%-75.6%) and 20.8% (95% CI, 5.1%-43.7%) in the IHC 3+ and IHC 2+ cohorts, respectively.

Safety was evaluated in 87 patients in HERIZON-BTC-01. A total of 96.6% of patients had any treatment-emergent adverse effects (AEs); 72.4% of patients had any treatment-related AEs (TRAEs; grade 1/2, 51.7%; grade 3/4, 20.7%). Overall, the most common any-grade TRAEs observed in patients treated with zanidatamab were diarrhea (36.8%), infusion-related reactions (33.3%), decreased injection fraction levels (10.3%), and nausea (9.2%).

Serious TRAEs occurred in 9.2% of patients who received zanidatamab. In total, 2.3% of patients who received zanidatamab permanently discontinued treatment with the agent due to an AE. However, at the long-term follow-up analysis, no patients had discontinued treatment due to a TRAE since the prior analysis. TRAEs leading to dose reductions included grade 3 diarrhea (n = 1), grade 1 diarrhea/grade 1 nausea (n = 1), and grade 2 weight decrease (n = 1).

One patient had a fatal AE of hepatic failure.2 However, no deaths on the trial were attributed to zanidatamab.

The ongoing, confirmatory phase 3 HERIZON-BTC-302 trial (NCT06282575) is evaluating frontline zanidatamab plus standard-of-care (SOC) therapy vs SOC therapy alone in patients with HER2-positive biliary tract cancer.1

1. Roche receives FDA approval for first companion diagnostic to identify patients with biliary tract cancer eligible for HER2-targeted treatment with ZIIHERA. News release. Roche. November 25, 2024. Accessed November 25, 2024. https://www.prnewswire.com/news-releases/roche-receives-fda-approval-for-first-companion-diagnostic-to-identify-patients-with-biliary-tract-cancer-eligible-for-her2-targeted-treatment-with-ziihera-302314548.html

2. Jazz Pharmaceuticals announces U.S. FDA approval of Ziihera® (zanidatamab-hrii) for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC). News release. Jazz Pharmaceuticals. November 20, 2024. Accessed November 25, 2024. https://investor.jazzpharma.com/news-releases/news-release-details/jazz-pharmaceuticals-announces-us-fda-approval-ziiherar

3. Pant S, Fan J, Oh D-Y, et al. Zanidatamab in previously-treated HER2-positive (HER2+) biliary tract cancer (BTC): Overall survival (OS) and longer follow-up from the phase 2b HERIZON-BTC-01 study. 

. 2024;42(suppl 16):4091. doi:10.1200/JCO.2024.42.16_suppl.4091

The FDA approved a companion diagnostic to identify patients with biliary tract cancer eligible for treatment with zanidatamab. 

FDA Approves Companion Diagnostic for Zanidatamab in Biliary Tract Cancer

Anne M. Reb, PhD, NP, discussing a nurse-led intervention for fear of cancer recurrence.

Shift in Nurse-Led Mindset Helps Quell Fear of Cancer Recurrence 

An intervention focusing on techniques to better focus patients’ attention may be beneficial in improving fear of cancer recurrence, according to recent research presented at the 21st International Conference of the Society for Integrative Oncology.

In a recent interview, study author Anne M. Reb, PhD, NP, discusses her abstract on a nurse-led videoconferencing intervention for patients with advanced cancer who may experience the fear of recurrence. Reb, who is an assistant professor of Nursing Research and Education at City of Hope, Duarte, California, explained that fear of recurrence is common, occurring in up to 70% of patients with advanced cancer.2 However, mindfulness interventions may help.

We teach mindset skills and we teach mindfulness-based skills. So we teach mindset skills to help people manage these thoughts and feelings that become sometimes overwhelming and intrusive, and we help them to know that they have more control over their thoughts than they think they have, because many people feel like they can't control their thoughts. None of us can control our thoughts and our feelings, they’re right.

But you can control where you focus your attention. You can choose how you manage these thoughts. And there's some exercises that you can do that we teach to help you better manage your thoughts. And you know, our thoughts and our feelings and our actions are all closely interrelated. Sometimes, if we have [a lot of] worries, [we may] believe that worry is really going to help us, or, in turn…that worry is harmful, these beliefs and these thoughts that we have influence our behaviors and our actions.

For example, some people might be so worried they feel like they need to worry, because it's going to help them keep on top of any new symptom that they get. They're going to report it to their doctor or to their nurse right away, so that if there is a cancer recurrence, they're going to catch it early. So, they think that worrying is going to protect them in some way.

Some people believe that worry is really harmful, and [they think] “worry is going to make my cancer come back,” or, “I believe that this new ache or pain that I'm having is going to mean that cancer is coming back.” Or they might think that their worries are uncontrollable, and that's a very common thing.

In this program, we teach them skills to think about how they're thinking. Our thought processes are very automatic, and we teach skills to notice your thought patterns, notice what you're believing, notice your actions.

So, for example, one patient, she was on the internet several times a day—up to 10 and 12 times—looking for new cancer trials and treatments. That was helping her to feel more comfortable that if…her cancer did progress, that she would be able to quickly tap into 1 of these new trials.

But I asked, “How's that working for you?” And she said, “Well, it's actually making me a little anxious, because I feel like I'm tired of the computer.” And I so I said, “Is there any way that you can cut back on that a little bit. How would that feel to you?” And she said, “Well, I could give that a try.”

So instead of checking the internet 10 times a day, she would check it in the morning and in the evening, and then that gave her more time to focus on what really was most important to her—spending time on things that she enjoyed, like pickleball and hanging out with her friends. So it really helps you to focus on the skills we teach to help you to really focus your attention with the goal of being able to have improved concentration and focus on the things that matter most to you.

1. Reb AM. A Nurse-Led Videoconferencing Intervention for Fear of Progression in Advanced Cancer: A Pilot Study. Presented at: 21st International Conference of the Society for Integrative Oncology. October 25-27, 2024.

2. Lebel S, Ozakinci G, Humphris G, et al. Current state and future prospects of research on fear of cancer recurrence. 

 Apr;26(4):424-427. doi: 10.1002/pon.4103.

“You can control where you focus your attention,” said Anne M. Reb, PhD, NP, who recently presented on a nurse-led intervention for patients who experience fear of cancer recurrence. 

Onc Nurse TV

Advanced Practice Corner

Shift in Nurse-Led Mindset Helps Quell Fear of Cancer Recurrence

Up to 75% of women being treated for breast cancer report that they have experienced sexual dysfunction; however, there is a lack of patient-provider communication about these issues.

, Michelle Taylor, ANP, discusses the importance of having these discussions about sexual health, and remedies that oncology nurses and advanced practice providers can recommend for patients experiencing these effects.

“The shift comes when you just try [to have these discussions]. Then next time you have the conversation, it’s a little easier,” Taylor, a nurse practitioner for adult patients at Dignity Health Cancer Institute at St. Joseph’s in Phoenix, AZ, said. “Sometimes even if you don’t know what advice to give to that woman, just being heard is something that is often very important.”

: Why is sexual health important in women with breast cancer?

 When you're a breast oncology-specific [health care provider], you have a large population, typically, of women, between the age of 40 and 60, and they're working, they're in relationships. It's just not something that's talked about enough.

I think vaginal health specifically should be talked about more, because whether someone is engaging in intercourse or not, we know that vaginal dryness can be tied to things like more frequent [urinary tract infections], more frequency of urination, and incontinence. These can be pretty debilitating side effects. No, it's not a grade 3 diarrhea that's requiring emergent intervention, but it is a major quality-of-life issue.

Is there a specific type of cancer treatment that affects vaginal and sexual health?

The truth of the matter is, depending on which literature you're looking at, nearly 85% of men and women can experience sexual side effects from any modality of treatment for cancer therapy, including traditional IV chemotherapy, certainly these oral medications and even things like radiation and surgical intervention.

Sexual dysfunction occurs mainly in the breast cancer setting, as we are lowering estrogen levels, even when it's not a direct medication that does this, such as [goserelin acetate [Zoladex]) injections or an aromatase inhibitor. There is ovarian suppression that comes from chemotherapy, for example.

What are common sexual adverse effects from breast cancer treatment, and are there ways to treat them?

So, the first mechanism is typically vaginal dryness, and that can be layering on top of an already existing vaginal dryness. And then [there are] physical effects of stenosis of the vaginal canal, making intercourse uncomfortable, and also just simply the reduction in libido. There’s body dysmorphia that can happen to a woman who has gone through breast surgery, radiation, chemotherapy, so the physical changes that can happen as well.

So there's many layers to sexual health in this setting. And I think that there are ways to help curb some of this. A lot of the women are coming in with those existing symptoms already, and then we're exacerbating them.

Teaching a woman up front, being comfortable yourself, having those uncomfortable conversations once you let a woman know that you're here and willing to talk about really anything that they're experiencing [is important], I think they become more comfortable sharing those things. We tend to recommend proactive moisturization with things as simple as coconut oil, which is very safe for external moisturization, as well as lubrication for intercourse, but there are also products that contain hyaluronic acid that are vaginal moisturization products that are very easy to use overnight.

I can go on and on about this. It's a personal passion of mine, based on what we see our women experience here, but it is something that all oncology nurses should be aware of, no matter what setting they're working in.

Hernández-Blanquisett A, Quintero-Carreño V, Álvarez-Londoño A, et al. Sexual dysfunction as a challenge in treated breast cancer: in-depth analysis and risk assessment to improve individual outcomes. 

A nurse practitioner discusses how breast cancer treatment can impact sexual health, and how nurses and APPs can guide patients through these effects. 

Sexual Health During Breast Cancer: ‘Just Being Heard Is Important’

Heather J. Jackson, PhD, APRN, FNP-BC, NEA-BC, FAANP in an interview with Oncology Nursing News

Tapering treatment with opioids for cancer-related pain can be a challenging process. However, when there is suspected opioid misuse, clinicians should consider faster tapering combined with non-opioid treatments to prevent harm to the patient or others, explained Heather J. Jackson, PhD, APRN, FNP-BC, NEA-BC, FAANP.

Jackson is the administrative director of advanced practice at Vanderbilt-Ingram Cancer Center and associate professor of Nursing and of Medicine in the Division of Hematology/Oncology

Vanderbilt University Medical Center. In a recent interview with 

, she discussed safe opioid tapering and multimodal pain management for patients experiencing cancer-related pain. The process, she explained, may look different in situations of misuse, she said, noting that potential signs of opioid misuse include:

Patients continuing to fill their prescription and request early refills, though no opioids are detected in urine samples (this can indicate that somebody else is taking the patient’s opioids or potential diversion)

Odd interactions with patients or family members regarding opioid use

Patients seeming to plan their daily schedule around taking opioids 

Patients indicating they are withdrawing from typical daily tasks or social activities with impacted relationships

Changes in mood such as irritability, nervousness, or fluctuations in emotions

“In a situation of misuse, we don’t want to put those drugs out there,” Jackson said. “We don’t want to harm the patient; we don’t want to harm other people. So we do have to do a rapid taper and offer alternative pain remedies as well as assess for substance use disorders.”

If we come upon a situation where we do [suspect] misuse, we discuss our concerns with the patient. Often a warning and limited number of opioid medications are prescribed and if misuse is validated, we proceed with a rapid taper. Our goal and our objective would be to be slow about this, and even have pauses in a taper. I've been known to spend a year-and-a-half with a patient that came to me on very high, extended-release regimens, and then with a short-acting [opioid prescription] on top of that…. I’ve had to pause, and they'll say, “it's a rough month … going on. Heather, can we please just pause there?” And absolutely you can do that.

But in a situation of misuse, we can't put those drugs out there. We don't want to harm the patient. We don't want to harm other people. So we do have to do a rapid taper, and in that situation, we'd want to address the symptoms of withdrawal, knowing that they can certainly be uncomfortable, but it's not going to harm the patient medically. We can give medicines to help with those symptoms. So we would want to treat any diarrhea. We can give medications to help with that sympathetic response in the nervous system.

Clinicians should consider a rapid taper approach for patients with cancer who exhibit repeated signs of opioid misuse, an expert said. 

Rapid Taper Plays Role in Suspected Opioid Misuse in Patients With Cancer

The new CAR-T cell therapy, anitocabtagene autoleucel (anito-cel), may offer another option beyond ciltacabtagene autoleucel (cilta-cel; Carvykti) for the treatment of patients with relapsed/refractory multiple myeloma, according to a data preview from the phase-2 iMMagine-1 trial (NCT05396885) trial released by Gilead Sciences and Arcellx.

Findings showed that per International Myeloma Working Group (IMWG) criteria, the investigator-assessed overall response rate (ORR) was 95% with a complete/stringent response rate of 62%. A total of 92% of eligible patients were minimal residual disease-negative, at least to the level of 10-5.

Kaplan-Meier-estimated 6-month progression-free survival (PFS) was 90% (95% CI, 77%-96%), and overall survival (OS) was 95% (95% CI, 85%-98%).

The median page age was 66 years, and the median follow-up was 10.3 months. Additionally, patients had received a median of 4 lines of therapy, with 45% having only 3. Of note, 69% of patients were triple-class refractory and 34% were penta-class refractory.

“Preliminary results from the first 58 patients in the phase 2 iMMagine-1 study demonstrate deep and durable responses and manageable safety in a high-risk fourth line or higher (4L+) [relapsed/refractory multiple myeloma] population including triple- and penta-class refractory disease,” the press release stated.1 “Notably, no delayed neurotoxicities, including no cranial nerve palsies, Guillain-Barré syndrome, or Parkinsonian-like symptoms have been observed with anito-cel to date.”

However, the FDA has previously placed a clinical hold on the phase 2 iMMagine-1 trial in June 2023 following a patient death that investigators attributed to limitations of the bridging therapy.

The hold was subsequently lifted in August 2023 after an investigation revealed that the death was a result of a patient who was treated with anito-cel after becoming ineligible for treatment under trial protocol before infusion with the drug and was treated in a manner that conflicted with the study’s protocol.

 The FDA approved dosing of all 17 patients enrolled in the trial prior to the partial clinical hold but had not yet been dosed before the hold, which reduced disruption of the treatment.

Anitocabtagene autoleucel may be a promising CAR-T cell therapy option for patients with relapsed/refractory myeloma. 

Mike Hennessy Jr

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