The FDA has approved an updated drug labeling for Sandoz's fludarabine phosphate injection in the treatment of B-cell CLL as part of the Oncology Center of Excellence's Project Renewal initiative.

The Food and Drug Administration (FDA) has approved updated drug labeling for fludarabine phosphate (Fludarabine Phosphate Injection; Sandoz) in the treatment of patients with B-cell chronic lymphocytic leukemia (CLL) under the Oncology Center of Excellence’s initiative, Project Renewal, according to a news release from the FDA.

The Project Renewal initiative is aimed at updating labeling information of older drugs for the treatment of cancer in order to ensure that information is clinically meaningful and scientifically up to date. Notably, this is the third drug to receive a labeling update under Project Renewal.

Furthermore, Project Renewal serves as a way to collaboratively leverage external oncology experts and early-career scientists in the review of existing literature that is published. This is done to gain first-hand experience in the evaluation of evidence for independent FDA review. The collaborative initiative is intended to provide transparency on FDA’s evaluation process and evidentiary standards, while keeping older, commonly prescribed oncology drugs’ labeling up to date. Additionally, Project Renewal is meant to improve the awareness of drug labeling as an information resource.

Furthermore, the news release noted that the initiative, while aiming to update oncology drug labels, still has limitations. The release notes that, “Project Renewal is limited to updating the label of older oncology drugs with decades of use and substantial post-marketing experience.”

The FDA: a government agency that protects public health by regulating the safety of food, drugs, medical devices, and other products.

Boxed warning: also known as a “black box” warning, is the most serious warning the FDA can issue for a drug.

Project Renewal: an initiative aimed at updating labeling information for older drugs for the treatment of cancer.

Labeling indication/information: this refers to the specific disease or condition that a drug is officially approved to treat, prevent, or diagnose.

At present, the injection of Sandoz is currently approved for two indications. In the first, Sandoz serves as a component of a combination regimen for the treatment of adults with B-cell CLL. In the second, the injection is utilized for the treatment of adults with B-cell CLL who have not responded to their current treatment, or whose disease has progressed while on a particular treatment, which contains at least one alkylating-agent containing regimen.

When looking to how these indications have changed, a boxed warning was removed from treatment with the Sandoz injection and is now instead incorporated into the Warnings and Precautions section of the label. The new and revised label indications also updated the dosing regimen of the agent; this was revised in order to include the recommended dosage for use in combination with cyclophosphamide and Rituxan (rituximab).

Previous dosing recommendations from the FDA cited a recommended dose of 25 milligrams per square meter in adults with B-cell CLL when administered intravenously over a period of approximately 30 minutes daily for five consecutive days; it was also noted that each five-day course of treatment should commence every 28 days. Additionally, the label stated to reduce the dose in patients with creatinine clearance between 30 and 70 milliliters per minute per square meter of body surface area.

The previous indication went on to note that there are some patients in which the agent is not recommended due to increased toxicity, including patients with advanced age, renal impairment and bone marrow impairment. These patients should be monitored closely for excessive toxicity and the dose should be modified accordingly.

Although the optimal duration of treatment has not been clearly established, it is recommended that three additional cycles of the injection are given following the achievement of a maximal response followed by the discontinuation of the drug.

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The FDA has updated the labeling for fludarabine phosphate, used in treating B-cell chronic lymphocytic leukemia (CLL), under Project Renewal. This initiative aims to modernize the labeling of older oncology drugs, ensuring clinical relevance and scientific accuracy. The updated label for fludarabine phosphate includes revised dosing regimens and the relocation of a boxed warning to the Warnings and Precautions section. The drug is approved for use in combination regimens for adults with B-cell CLL, particularly those unresponsive to current treatments or with disease progression.

The FDA has approved updated drug labeling for Sandoz in the treatment of B-cell chronic lymphocytic leukemia.

The FDA Approves Labeling Update for Sandoz in the Treatment of B-Cell CLL 

CURE® spoke with a physical therapist specializing in oncology to find out more about this condition some patients with cancer are at risk for.

1 min

There are a number of factors that patients with breast cancer need to keep in mind regarding lymphedema, as one expert detailed in an interview with 

A condition where protein-rich fluid builds up in the space between the skin and muscle of a body part, lymphedema is of particular concern for patients with cancer who have lymph nodes removed.

Leslie Waltke, a physical therapist who specializes in oncology, founder of the Waltke Cancer Rehabilitation Academy and a member of the 

 advisory board, discussed topics including who is at risk for lymphedema, how precautions are changing around it and the work she does with patients with lymphedema.

Axillary surgery: the removal lymph nodes in the armpit region

Sentinel lymph node biopsy: the removal of the first lymph node where the cancer has most likely spread to from a primary tumor, and can involve multiple nodes

CURE: Is there anything that patients with breast cancer specifically should keep in mind regarding lymphedema?

 Well, first of all, updating their knowledge of what is their actual specific risk. Because again, it's not the breast surgery that causes the risk, it is their lymph node removal during the axillary dissection or the sentinel lymph node biopsy that puts you at risk. So, if you have a mastectomy but [have] no lymph nodes removed, you are not at risk for lymphedema. So, it's not the breast surgery, it's the axillary dissection, and radiation to the armpit can change that just a little bit as well. So those are the two factors. What is your specific risk? That, you're going to get that from your surgeon.

And again, [there are] the changing precautions of if somebody comes to me and they're at risk, the first thing I'm going to do is have them stretch out their armpit, make sure that arm is fully mobile, that the skin moves well, the range motion of the shoulder is completely normal, and that they are have normal strength again, because that, again, protects the limb from swelling problems. And then after that's all good, so that arm is 100% range of motion, 100% strength, 100% tissue mobility, it's happy, then I'm going to say to that person, “OK, I want you exercising regularly. I want you taking walks or bicycle rides five times a week. I want you lifting weights twice a week.” Because that, in addition, will significantly decrease lymphedema risk.

And then again, making sure that you're following actually evidence-based precautions [is important]. There is no evidence that if you fly it increases your risk of lymphedema. There is no evidence that getting a blood pressure [check] on your involved arm or getting a blood draw on your involved arm increases risk, if you are at risk for lymphedema but don't have it. So just understanding really what your risk is and what the true precautions are, and then again, making sure you're getting into physical therapy and making sure that that limb should be as good as it was, if not better than before surgery.”

Transcript has been edited for clarity and conciseness.

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Lymphedema, a condition where protein-rich fluid accumulates between the skin and muscle, is a concern for cancer patients undergoing lymph node removal. Leslie Waltke, an oncology-focused physical therapist, emphasizes the importance of understanding specific lymphedema risks, which are primarily associated with axillary dissection and radiation, not breast surgery itself. She advocates for maintaining full arm mobility, strength, and tissue health, alongside regular exercise, to mitigate lymphedema risk. Waltke also highlights the need for evidence-based precautions, debunking myths about flying and blood pressure checks.

What Patients with Breast Cancer Need to Know About Lymphedema Risk

New treatments for acute lymphoblastic leukemia may lead to fewer side effects than chemotherapy, as they target cancer cells more precisely, an expert said.

Newer Therapies for Acute Lymphoblastic Leukemia May Reduce Side Effects 

Newer treatments for patients with acute lymphoblastic leukemia may offer the potential for fewer side effects than traditional chemotherapy, an expert said.

These innovative therapies, including drugs like Besponsa (inotuzumab), glembatumumab and Blincyto (blinatumomab), target cancer cells more precisely, reducing the impact on healthy cells. This can lead to fewer side effects such as low blood cell counts and liver problems, which are common with chemotherapy.

Cytokine release syndrome: a large, rapid release of cytokines from immune cells into the blood that may result from immunotherapy. Symptoms may include nausea, fever, rash, headache, low blood pressure, rapid heartbeat and trouble breathing.

Immune effector cell-associated neurotoxicity syndrome: a neurological condition when the immune system causes inflammation in the brain, which may lead to mild to severe symptoms affecting movement, cognitive functions and speech.

Cytopenia: lower than normal number of blood cells.

Transaminitis: elevated levels of transaminases, a liver enzyme, in the blood, which may indicate liver damage.

Vaso-occlusive disease: when blood vessels become blocked by clumping of red blood cells, which can prevent blood flow to certain areas of the body.

Hyper-CVAD: a chemotherapy regimen used to treat some types of lymphoma and leukemia.

Febrile complications: issues that can occur as a result of a fever. 

At the 43rd Annual Chemotherapy Foundation Symposium, CURE® spoke with Dr. Hannah Levavi to learn more about these new treatments. Particularly, we discussed how these newer treatments compare with chemotherapy regarding side effects, and how to best optimize treatment plans.

Levavi is an assistant professor of medicine, hematology and medical oncology at The Tisch Cancer Institute at Mount Sinai Hospital in New York.

So one real benefit of the novel therapies is that they're much more tolerable, especially in an older population, than traditional chemotherapy. So while both inotuzumab (Besponsa) and glembatumumab do have toxicities, blinatumomab (Blincyto) has CRS (cytokine release syndrome) and ICANS (immune effector cell-associated neurotoxicity syndrome), as well as some degree of cytopenias and transaminitis. And inotuzumab, of course, has a risk of transaminitis as well as vaso-occlusive disease. These side effects are much more tolerable for most patients than traditional chemotherapy, especially when comparing these to very common chemotherapy backbones that are used in the community, like Hyper-CVAD, so patients don't develop the same degree of cytopenias. They don't develop the same degree of febrile complications. So these are really very tolerable.

There — and as we work through these therapies, we're learning more about how to refine the way we dose them and the way we manage the adverse events in order to mitigate some of these toxicities, such as reducing the dose and fractionating inotuzumab.

Newer treatments for acute lymphoblastic leukemia, such as Besponsa, glembatumumab, and Blincyto, offer a more targeted approach, potentially reducing side effects compared to traditional chemotherapy. These therapies are particularly beneficial for older patients, as they are more tolerable and result in fewer complications like cytopenias and febrile episodes. Despite some toxicities, such as cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome, these side effects are generally more manageable. Ongoing research aims to optimize dosing and management of adverse events to further enhance tolerability.

Venclexta is effective in treating patients with AML and MDS, offering survival benefits and a manageable safety profile, according to a study.

Among patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS), treatment with a Venclexta (venetoclax)-based regimen was shown to have survival benefits as well as a manageable safety profile, researchers have found.

The real-world study by the Turkish Hematology Network Group, findings from which were published in 

, analyzed clinical and laboratory data of adult patients with AML or MDS who were treated with Venclexta between January 2019 and January 2022, with survival calculations based on the period of 2019 to December 2023, with 161 patients with AML and 40 patients with MDS included in the research.

Most patients — 77.6% of those with AML and 75% of those with MDS — had received treatment before Venclexta. In addition, researchers reported that Venclexta had been administered in combination with azacitidine for most patients, including 84.5% of those with AML and 67.5% of those with MDS.

Acute Myeloid Leukemia (AML): a type of cancer in which the bone marrow makes a large number of abnormal blood cells, according to the National Cancer Institute.

Myelodysplastic Syndromes (MDS): a group of cancers in which immature blood cells in the bone marrow do not mature or become healthy blood cells, according to the National Cancer Institute.

Venclexta (venetoclax): a drug approved for the treatment of AML and MDS, according to the National Cancer Institute.

Real-world study: a study conducted outside of a clinical trial setting.

Azacitidine: sold under the brand names Onureg and Vidaza, it is a drug approved to treat AML and MDS, according to the National Cancer Institute.

Overall survival: the time a patient lives, regardless of disease status.

Complete remission: the disappearance of all signs of cancer in response to treatment.

Relapse-free survival: the time after treatment that a patient lives without signs or symptoms of cancer.

Researchers reported that the overall two-year overall survival rate was 46%, and the median overall survival time was 18.73 months. For patients with AML, the two-year overall survival rate was 44.1%, while it was 52.7% among patients with MDS.

Among patients with AML, complete remission with incomplete blood count recovery occurred in 31.5% of patients, while 22.6% of patients achieved complete remission, with those rates being 37.5% and 25% among patients with MDS. Remission was achieved by 57.1% of patients with AML and 60% of patients with MDS.

The two-year relapse-free survival rate was 75.5% among patients with AML and 90.9% for patients with MDS, researchers noted.

Regarding side effects, 26.7% of patients with AML and 15% of patients with MDS experienced side effects that were severe (grade 3) or life threatening (grade 4) leading to treatment discontinuation, while side effects that required dose modification occurred among 47.2% of patients with AML and 37.5% of patients with MDS.

“[Venclexta] exhibits a low toxic profile, a low relapse rate and very rare adverse events leading to treatment discontinuation,” researchers concluded in their findings. “These results suggest that [Venclexta] treatment may offer significant clinical responses in both disease groups [of patients with ALM and MDS]. Overall, this study highlights the potential of [Venclexta] to achieve higher overall survival rates when used in combination therapies.”

“Multicentral Retrospective Analysis of Venetoclax-Based Treatments in AML and MDS: A Real-World Study by the Turkish Hematology Network Group” by Dr. Ibrahim Halil Acar, et al., 

Venclexta (venetoclax)-based regimens have demonstrated survival benefits and a manageable safety profile in patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). A real-world study by the Turkish Hematology Network Group analyzed data from 2019 to 2023, involving 161 AML and 40 MDS patients. The two-year overall survival rate was 46%, with a median survival of 18.73 months. Remission rates were notable, and the relapse-free survival rate was high. Side effects were generally manageable, with a low incidence of severe adverse events leading to treatment discontinuation.

Researchers have found an overall survival benefit and manageable safety profile with Venclexta for patients with AML and MDS.

Venclexta Regimen Beneficial for Patients with AML and MDS

Kelly Irvin was diagnosed with stage 4 ovarian cancer in January 2016. Catch up on all of 

I’m coming up on the ninth anniversary after my diagnosis of stage 4 ovarian cancer in January 2016. As always, this causes me to ponder my life as someone living with cancer for the rest of my life. I ponder why I’m still here and others are not. Have I used this time well? What have I learned that might be of use for other “lifers,” as well as those just starting on this journey? It’s that last question I’m focused on here. The following is my top 10 list for living with cancer when there’s no likelihood of hearing those magical words “cancer-free.”

No one will do it better. I consider myself a member of my care team. I make lists of questions to ask. If I don’t understand the answer, I ask for a response in plain English. I study my insurance benefits and I’m not afraid to call the company to clarify benefits. Learn to read explanations of benefits (EOBs). I’ve had to learn to stand my ground with billing personnel and office staff members who assume I have no idea what I’m talking about. I’ve had to get over feeling like the grumpy/difficult old lady.

Using reliable sources such as chemocare.com, the American Cancer Society, the National Institute of Health, the CDC and clinicaltrials.gov, allows me to stay current about my disease, standard of care treatments and clinical trials.

3. Practice being kind, respectful and patient.

That last one is particularly hard for me. (See No. 1.) I’ve spent so much time sitting in waiting rooms, that I sometimes border on exploding. A balance is needed. Patients’ time is valuable too. But other patients may require additional time from your doctor too. He or she may fall behind. I want him to give me that same attention, so I should give the same grace to others.

When I celebrated my third anniversary at the phase 1 clinical trial where I’m currently in treatment, I bought joke books for the infusion room and the nurse and doctors' station. They are special people in a horribly difficult specialty. Sometimes we all have to laugh in order to keep from crying.

5. Find outlets for your anxiety and stress.

I live in three-month increments from CT scan to CT scan and tumor marker test results once a month. How do I keep from obsessing about results? I write fiction for a living. Writing gives me joy and keeps my mind off my problems. Reading is my favorite pastime. I belong to a bible study, attend church and Sunday school. Exercise, baking, volunteering, fishing, sewing, pottery—whatever works.

In other words, live your life. When I was first diagnosed, I was afraid to sign a new four-book contract. A friend reminded me that I could get hit by a bus tomorrow. So could the next person. I take trips, play with my grandkids, celebrate anniversaries and spend time with my husband.

Have at least one person to whom you can vent. For some people, support groups work. My “buddy” is a woman living with AML whom I met through an online support group supposed to last for four weeks. Like me, she is in a clinical trial. We’ve been meeting online about once a month for three years. We voice our fears, complain, give each other advice, laugh and be snarky. We understand how hard it is to live like this.

8. Don’t wait until all other treatments have been exhausted to consider clinical trials.

I’ve been in one that’s working for two years. Incredible work is being done in targeted treatments. Talk to your doctor about genetic testing. Work with them to use the results to determine if there’s a clinical trial that will work for you.

Palliative care is a balanced team approach to care that makes sure all of your needs are addressed, including your mental health, to give you the best quality of life. I had to sign a document saying I understood my care was palliative, not curative, during chemo education early in my treatment. I resented it at the time (rubbing salt in the wound), but now I have a better understanding of the term. Hospice is end-of-life care.

10. Know your feelings regarding quantity of life versus quality of life.

Know which is more important to you. Living with drug side effects and endless medical appointments hasn’t been pleasant, but I do it because I want this time with my family. I also still have stories to write. My oncologist says new treatments are coming down the pike fast and furiously. That gives me hope and the strength to persevere. The day may come when I feel differently, but that day isn’t today.

One final word comes from the oncologist who took care of me for the first five years. The first time I had no evidence of disease (NED), I had to start maintenance treatment. I asked her for how long and she said until there was disease progression. I couldn’t wrap my head around living like this for the rest of my life. She said, “You’re living in a new world now. You can’t go back to the old world. But you’re in a really good place in this world. Hang on to that.”

A recurrence occurred eleven months later. Nine years later, I’m still hanging on to her words.

Living with stage 4 ovarian cancer for nine years, the author shares insights on navigating life with a chronic cancer diagnosis. Emphasizing self-advocacy, research, and maintaining a sense of humor, the author highlights the importance of balancing quality and quantity of life. Engaging in activities that alleviate stress and making memories are crucial. The author underscores the significance of understanding palliative care, considering clinical trials early, and having a support system. The journey is about adapting to a new reality while cherishing the present.

Nine years as an ovarian cancer “lifer” yields these tips for surviving and thriving when there’s no end of treatment ahead. 

My Top 10 List for Living With Cancer 

A patient with small cell lung cancer shared her clinical trial experience with CURE® and how she encourages other patients with cancer to enroll.

Why Clinical Trials Don’t Have to Be Patients’ ‘Last Line of Defense’

Wendy Brooks told CURE® that she feels “blessed” to be part of a clinical trial evaluating the antibody-drug conjugate ABBV-706 in small cell lung cancer.

“I am at 65% reduction [of disease] from baseline based on where I was [before I started the trial] in the March, April time frame with those CT scans,” said Brooks, who has limited-stage small cell lung cancer. “We were doing nothing but shrinking and no spread and I cannot ask for any better results. To me, in this small cell cancer, that's huge. It's a huge win.”

Brooks received her diagnosis of lung cancer in July 2023 and underwent chemotherapy and radiation. The cancer eventually spread to her brain, for which she received Gamma Knife surgery, and then it returned to her lungs and spread to her lymph nodes.

Limited-stage small cell lung cancer: when lung cancer is found on one side of the chest.

ABBV-706 is currently the subject of a clinical trial to assess its safety, tolerability, pharmacokinetics and efficacy both as a stand-alone monotherapy and in combination with budigalimab, carboplatin or cisplatin in the treatment of small cell lung cancer, high-grade central nervous system tumors and high-grade neuroendocrine carcinoma, according to the National Cancer Institute.

Antibody-drug conjugates such as ABBV-706 are targeted therapies that contain a monoclonal antibody directed toward a target on a cancer cell that is linked to a cancer-killing drug payload.

“It was explained to me as it was a targeted therapy directly to the SEZ6 (seizure-related homolog 6 protein) expression that our cancer has,” said Brooks. “There's no testing for it, about 80% to 85% of the small cell patients have that expression. My doctor felt that … I was a good match for it, just based on — I don't have any other comorbidities to speak of that would limit me in choices for trials. … And boy, was he right. That was the best decision we could have made.”

A patient advocate for LiveLung, Brooks shared her advice for other patients who may be considering clinical trial enrollment.

CURE®: What advice do you have for any patients who may be considering enrolling in a clinical trial?

I would definitely encourage folks [to enroll]. It's not your last line of defense. It's definitely [that] you are getting advanced treatment now, and helping not only you but others that are fighting this disease to be able to give us the data that's necessary in order to get these drugs approved for the masses. Because we don't have a whole lot of weapons in our arsenal, so to speak, and the clinical trials do give us that opportunity to test on a human and show those results, take the theory from the lab to the patient and be able to help all of us. Now it's selfish, a little bit, but it's also to help everybody else that's fighting this nasty disease.

Wendy Brooks, a patient with limited-stage small cell lung cancer, is experiencing significant disease reduction through a clinical trial involving the antibody-drug conjugate ABBV-706. This trial evaluates ABBV-706's safety, tolerability, pharmacokinetics, and efficacy, both as monotherapy and in combination with other treatments. ABBV-706 targets the SEZ6 protein, prevalent in small cell lung cancer. Brooks advocates for clinical trial participation, emphasizing its role in advancing treatment options and contributing to broader cancer research efforts, benefiting both individual patients and the wider community.

A common side effect associated with Columvi included cytokine release syndrome, research showed.

Among heavily pre-treated patients with relapsed or refractory mantle cell lymphoma, fixed-duration Columvi (glofitamab) demonstrated high complete response rates and a manageable safety profile with appropriate support, according to study findings published in the

After a median follow-up of 19.6 months, the complete response (CR) rate was 78.3% and the overall response rate (ORR) was 85%. Out of 31 patients who had received previous treatment with a Bruton tyrosine kinase inhibitor, the CR rate was 71% and the ORR was 74.2%. After the administration of Columvi, cytokine release syndrome occurred in 70% of patients, including a lower incidence for patients with Gazyva (Obinutuzumab) pretreatment (Gpt) who received 2,000 milligrams (63.6%) compared with those receiving 1,000 mg (87.5%).

“Responses were highly durable beyond end of treatment, and a fixed treatment duration (approximately 8.5 months) may help reduce the treatment burden for patients with [relapsed or refractory mantle cell lymphoma],” study authors wrote.

Cytokine release syndrome: it is caused by a large, rapid release of cytokines into the blood from immune cells affected by the immunotherapy.

Complete response rate: percentage of patients whose cancer completely disappears.

Overall response rate: percentage of patients whose cancer shrinks or disappears.

Duration of complete response: average length of time a complete response last.

Fixed-duration treatment: treatment given for a set period of time, regardless of response.

Regarding side effects, all patients experienced at least one or more, with the most common being cytokine release syndrome (CRS; 70%), neutropenia (38.3%) COVID-19 (31.7%) and pyrexia (31.7%). Severe or life-threatening side effects occurred in 65% of patients, with common side effects including neutropenia (23.3%), pneumonia (11.7%), anemia (11.7%) and CRS (11.7%).

Serious side effects were experienced by 78.3% of patients. These included CRS in 36.7% of patients and infections in 33.3%. In addition, eight patients died due to infection, with one each from septic shock, post-acute COVID-19 syndrome and pneumonia, and five from COVID-19 or COVID-19 pneumonia.

Furthermore, side effects leading to interruptions in Columvi dosing were reported in 36 out of 60 patients. The most common side effects included COVID-19 or COVID pneumonia (15%), neutropenia (15%), cytokine release syndrome (10%) and pneumonia (10%). Additionally, four out of 60 patients (6.7%) had to withdraw from Columvi treatment due to side effects, all of which were infections.

In the 1,000-milligram (mg) Gpt cohort, CRS events were reported in 87.5% of patients. In the 2,000 mg Gpt cohort, CRS events were reported in 63.6% of patients. One patient in the 1,000 mg Gpt cohort died due to progressive disease while experiencing an ongoing CRS event, but all other events had resolved. CRS events primarily occurred during cycles one and two. No deaths related to CRS were reported.

“The safety profile of [Columvi] was predictable and manageable with appropriate support, with a lower rate of CRS events observed with 2,000 mg versus 1,000 mg Gpt,” study authors wrote.

A total of 60 patients, with a median age of 72 years, who underwent at least one previous line of therapy were included in the trial.

Patients received Gpt at a dose of either 1,000 mg or 2,000 mg for seven days before the first dose of Columvi. The initial dose of Columvi could be administered as a single dose or divided over two days if required. Step-up dosing of Columvi was given once daily on day 8 (2.5 mg) and day 15 (10 mg) of Cycle 1. Starting on day 1 of cycle 2, the target dose was either 16 mg or 30 mg, administered once every three weeks for a total of 12 cycles.

“Fixed-duration treatment with off-the-shelf [Columvi] monotherapy achieved high CR rates in heavily pretreated patients with R/R MCL, including patients previously treated with a BTKi,” study authors concluded.

“Glofitamab in Relapsed/Refractory Mantle Cell Lymphoma: Results From a Phase I/II Study” by Dr. Tycel Jovelle Phillips, et al., 

Columvi (glofitamab) demonstrated high complete response rates in heavily pre-treated relapsed or refractory mantle cell lymphoma patients, with a CR rate of 78.3% and an ORR of 85%. The treatment showed a manageable safety profile, with cytokine release syndrome (CRS) occurring in 70% of patients, but with a lower incidence in those pre-treated with higher doses of Gazyva. Severe side effects were common, with 65% experiencing severe or life-threatening events. Fixed-duration treatment may reduce the treatment burden, offering durable responses beyond the end of treatment.

Treatment with Columvi showed a manageable safety profile in heavily pre-treated patients with relapsed or refractory mantle cell lymphoma.

Columvi Shows High Response Rates and Safety in R/R Mantle Cell Lymphoma

A phase 3 trial will be discontinued after two treatment groups showed similar outcomes. 

The primary end point was not met in a phase 3 trial for patients newly diagnosed with high-risk myelodysplastic syndromes (MDS) who have a RARA gene overexpression. Trial investigators plan on discontinuing the trial following the missed end point.

The phase 3 SELECT-MDS-1 trial did not meet its primary end point of complete response (CR) rate, as stated in a news release from Syros Pharmaceuticals, the manufacturing company of tamibarotene. Patients in the trial have newly diagnosed high-risk MDS and received a treatment combination of tamibarotene and Vidaza (azacitidine).

Tamibarotene is an oral treatment, whereas Vidaza is a type of injection that is used to treat MDS, according to the National Cancer Institute.

Primary end point: the main goal measured after a study is completed.

Complete response (CR): percentage of patients who fully responded to treatment, demonstrating cancer disappearance.

Event-free survival: time patients live without experiencing complications after receiving treatment.

Overall survival: time patients live, regardless of their disease status.

Overall response: patients who have a CR or a partial response to treatment; demonstrating a disappearance of cancer or some tumor shrinkage.

The main goal of the trial was to see CRs among at least the first 190 patients enrolled in the study, according to the news release. However, the researchers found that in 126 patients, the CR rate in the tamibarotene-Vidaza group was 23.8%. This CR rate outcome was compared with a CR rate of 18.8% in 64 patients who received placebo (inactive drug) plus Vidaza, the release stated. Researchers established that the differences between the CR rates from the two treatment groups were not statistically significant enough.

“We are deeply disappointed by this outcome, particularly for the high-risk MDS patients who are seeking a new treatment option for this challenging disease,” said Conley Chee, chief executive officer of Syros, in the news release. “We plan to stop the study, review the clinical data more thoroughly and evaluate the next steps.”

‘Tempo’ of MDS Helps With Timing for Stem Cell Transplants

Regarding safety, the researchers on the trial found that 160 patients who received the tamibarotene-Vidaza combination generally tolerated the treatment well.

The phase 3 SELECT-MDS-1 trial began in early 2021, according to its clinicaltrials.gov listing. Patients in the trial were assessed for their RARA biomarker, which was observed after researchers received blood samples. Researchers randomly assigned patients to either the tamibarotene-Vidaza group or the placebo-Vidaza group.

In the tamibarotene-Vidaza group, patients received 6 milligrams (mg) of tamibarotene orally twice daily on the eighth day of a 28-day treatment cycle, according to clinicaltrials.gov listing. Patients also received 75 mg per square meter of Vidaza, which was either intravenous (through the vein) or subcutaneously (injected) every day for the first through seventh day in the 28-day treatment cycle.

Financial Burdens Harm Quality of Life After Stem Cell Transplants

In patients from the placebo-Vidaza group, placebo was given orally twice daily on the eighth day of the 28-day treatment cycle. Patients then received Vidaza at 75 mg per square meter on the first through seventh day of each 28-day treatment cycle, the listing explained.

The trial’s secondary end points included — but were not limited to — event-free survival, overall survival, how long CR lasted, overall response and the number of patients who achieved blood transfusion independence.

For more news on cancer updates, research, and education, don’t forget to 

A phase 3 trial for high-risk myelodysplastic syndromes (MDS) with RARA gene overexpression failed to meet its primary endpoint of complete response (CR) rate. The trial, involving tamibarotene and Vidaza, showed a CR rate of 23.8% compared to 18.8% in the placebo group, lacking statistical significance. Despite good tolerability, the trial will be discontinued. Initiated in 2021, the trial assessed RARA biomarkers and included secondary endpoints like event-free survival and blood transfusion independence. Further data review and next steps are planned by Syros Pharmaceuticals.

A trial evaluating the tamibarotene-Vidaza combination in certain patients with newly diagnosed high-risk MDS will be discontinued.

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