Tag Archive for: vaccine

Updates in AML Treatment and Research From ASCO 2023

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Updates in AML Treatment and Research From ASCO 2023 from Patient Empowerment Network on Vimeo.

AML expert Dr. Omer Jamy shares highlights from the recent American Society of Clinical Oncology (ASCO) annual meeting, including an update on an immunotherapy agent showing promise as well as a vaccine therapy being studied for patients in a second remission.

Dr. Omer Jamy is a Leukemia and Bone Marrow Transplant Physician and Assistant Professor at the University of Alabama at Birmingham. Learn more about Dr. Omer Jamy.

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Transcript:

Dr. Omer Jamy:

My name is Omer Jamy, and I’m a leukemia and bone marrow transplant physician at the University of Alabama at Birmingham. And I’m really happy to be here today.  

Katherine Banwell:

Well, thank you. Dr. Jamy, the ASCO 2023 meeting just wrapped up recently. What were the highlights in AML research from that meeting? 

Dr. Omer Jamy:

Thank you. Yeah. There were several interesting studies in AML presented at ASCO this year. I’d like to highlight a couple of them in particular mainly because the focus on a novel mechanism of action, at least for patients with acute myeloid leukemia. And that mechanism of action being immunotherapy. So, we’re all aware that immunotherapy has had tremendous results in solid tumors.   

It’s making its way into hematological malignancies mainly lymphomas as well as B-cell ALL which is acute lymphoblastic leukemia. And we are trying to investigate it in patients with AML as well.  

And I think in that context there were a couple of abstracts which I thought were really interesting. The first one was actually presented by Dr. Anthony Stein and colleagues. Looking at a drug which is basically CD123 NK-cell engager.  

And I spent a little bit trying to explain what that is, but basically, it’s a drug which it harnesses the person’s immune system to fight the cancer basically. So, it targets an antigen which is expressed on leukemia cells called CD123. And it binds it to natural killer cells or NK cells. So, this drug is taking the host which is the patient’s natural killer cells and the leukemia cells and binding them together and then leads to the activation of the NK cells which causes killing of the leukemia cells.  

So, I think that mechanistically speaking that’s a very interesting concept to fine tune the person’s own immune system to fight the leukemia. This is obviously very early in development, so it’s a Phase I study, Phase I/Phase II. And they have presented results in 23 patients with relapsed/refractory AML.  

And just to give you some background, CD123 is expressed in the majority of patients with acute myeloid leukemia. It’s also expressed in patients with myelodysplastic syndrome as well as ALL. So, the study had all three diseases, but we’re going to focus on AML today. So, there were 23 patients with acute myeloid leukemia in the study. And because it’s a Phase I study, they have to test it at the lowest dose, and then assess for safety, and then keep on going up on the dose. So, they actually looked at six dose levels. And luckily because it’s a Phase I, the primary objective is to make sure it’s a safe drug to administer.  

And then second your objectives are basically if it’s efficacious or not. So, there were no dose limiting toxicities in the 21 evaluable patients out of the 23. So, that’s good. I think the lowest dose was 100 micrograms per kilograms per day. And the highest dose was 3,000 micrograms per kilogram per dose. The doses IV once or twice a week for the first couple of weeks, and then followed by weekly administration. In 23 patients the drug was thought to be safe. Again, no dose limiting toxicities.  

With immunotherapy you worry about side effects such as cytokine release syndrome because you are basically putting your immune system in overdrive. So, you don’t want to make sure your immune system doesn’t wreak havoc on the body itself. So, cytokine release syndrome or CRS as well as associated neurotoxicity are two common side effects of most of these novel immunotherapies.  

Which for the general audience, if they’ve heard about CAR T therapy or antibody drug conjugates or bispecifics, these are all under the same umbrella of immunotherapy. So, their side effect profile is pretty overlapping and different from what would be seen with conventional chemotherapy. So, they saw no neurotoxicity. And they saw CRS which was very manageable, right? Grade 1 or Grade 2 in a couple of patients. And as far as efficacy was concerned, out of the 23 patients they saw a response in three patients. Now that doesn’t sound very appealing, but you have to realize these are starting at a very low dose level and going up. So, when they looked at patients who were getting a dose of 1f,000 micrograms per kilograms per day, so a pretty hefty dose. Three out of eight patients, which roughly translates to 40% of the patients, achieved a remission. So, which to me for relapse refractory population is attractive. And it makes me want to investigate this molecule further.  

And that is exactly what’s going on currently with the study. And I think again CD123 is an interesting target. The other companies targeting as well either as NK-cell engagers or antibody drug conjugates with other payloads. So, this is an area of active investigation. So, that’s where – 

Katherine Banwell:

You said – 

Dr. Omer Jamy:

Yeah.  

Katherine Banwell:

Yeah, you said there was another study. Could you briefly tell us about that.  

Dr. Omer Jamy:

Exactly. So, the other study is also harnessing the person’s immune system to fight leukemia in a very different way. And this is a randomized Phase III study, ongoing. It’s international. And it’s a trials in progress meaning that it’s accruing across the country, or actually across the globe. And I wanted to highlight this in case people want to reach out to centers where this study is ongoing and want to participate in it. This is a trials in progress poster of a compound called GPS which is basically a vaccine against a protein called Wilm’s tumor 1 or WT1 which is vitally expressed on leukemia cells as well.  

Now this is a tumor vaccine actually which is a novel concept of an AML. So, vaccines as you know, are better at prevention than treatment. So, this is a maintenance drug for people in second remission or beyond who are unable to proceed to stem cell transplantation.  

So, they get the opportunity to enroll in this Phase III which is a randomized study of either GPS versus a physician’s choice which includes a wide variety of agents to choose from making it a pretty reasonable control arm and follows patients to see if the primary end point being overall survival. So, I think again for patients who achieve second remission or beyond ideally, they should proceed to stem cell transplantation. But there are several barriers to that including advanced age, comorbidities, socioeconomic barriers. So not everyone can proceed. So, for patients in that situation, there is no standardized maintenance therapy.   

And in that context I feel like an immunotherapy agent basically this vaccine which has shown very promising results in single-arm Phase I, Phase II studies is now being investigated in a Phase III study. And because it’s a trials in progress I cannot share any results with you because we don’t have any results. But I feel like people should know about this because it is open at 20 to 30 centers in the US.  

And it’s an option out there for patients who would like to participate in such a clinical trial. 

Is COVID-19 Vaccination Safe and Effective for DLBCL Patients?

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Is COVID-19 Vaccination Safe and Effective for DLBCL Patients? from Patient Empowerment Network on Vimeo.

Is COVID-19 vaccination safe and effective for diffuse large B-cell lymphoma (DLBCL) patients? Dr. Jean Koff shares what’s currently known about COVID-19 vaccination for DLBCL patients and provides information about studies currently underway on immunocompromised patients.

Dr. Jean Koff is an Assistant Professor in the Department of Hematology and Oncology at Winship Cancer Institute at Emory University. Learn more about Dr. Koff, here.

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Transcript:

Katherine Banwell:

A question that’s on many people’s minds right now is if the COVID 19 vaccination is safe and effective for people with DLBCL? 

Dr. Koff:

So, I don’t think we have any reason to believe that it’s not safe. We haven’t seen any signals that it is not safe. I think there are reasonable concerns that for patients who either have active lymphoma where the lymphoma may be impacting their immune system and the immune system’s ability to mount the response that you need to get immunity when you get vaccinated. But even more so patients who are receiving some sort of therapy, especially chemotherapy and immunotherapy. Those types of treatments actually may knock out the same normal bystander immune cells that help you mount that immune response when you get vaccinated.   

And so, the concern there is that in those individuals either with active DLBCL or who are receiving treatment for DLBCL, that their immune systems might be somewhat compromised and not able to mount as robust of an immune response when they get vaccinated. 

And by extension, the vaccine may not work as well to protect them against COVID as it would in somebody who doesn’t have a compromised immune system. But what I’m counseling my patients is that if they are not actively receiving treatment that impacts their immune system like chemo or immunotherapy, I am recommending that they go ahead and get the vaccine.  Because to me the risk of COVID and COVID-related complications is very high. And the risk of complications from the vaccination is very low. And the protection that it offers – while we are not sure the level of protection that it offers in these special cases, some protection, if it does offer it is better than no protection. And the risk of immunization is low. We are actually doing the studies now at Emory.  

In specifically lymphoma patients who get the COVID vaccine. Whether they have active lymphoma or getting treatment in lymphoma, we’re doing the studies now to take a look and see whether they’re able to adequately mount immune responses to the COVID vaccine. So, that we can better counsel our patients on how effective these vaccines will be.   

So, once we have more mature data from our studies and from other centers, similar studies, we’ll be able to better estimate what the chances that the vaccine will be protective for an individual patient.

NCCN Guidance on Safety and Effectiveness of COVID-19 Vaccines for Cancer Patients

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NCCN Guidance on Safety and Effectiveness of COVID-19 Vaccines for Cancer Patients from Patient Empowerment Network on Vimeo.

Is the COVID-19 vaccine recommended for people living with cancer? Dr. Erin Roesch shares recommendations from the National Comprehensive Cancer Network (NCCN) for those undergoing cancer treatment, including guidance on mask wearing and advice for family members.

Dr. Erin Roesch is a breast medical oncologist at the Cleveland Clinic. Learn more about Dr. Roesch here.

Transcript:

Katherine: 

Many cancer patients have questions about the COVID vaccine. Is it safe? Do we need to continue wearing masks? Here to address these questions is cancer expert, Dr. Erin Roesch. Dr. Roesch, would you introduce yourself?

Dr. Roesch: 

Hello. And thank you for inviting me to participate in this very important conversation. My name is Erin Roesch. I am a breast medical oncologist at Cleveland Clinic.

Katherine: 

Excellent. Thank you so much for joining us today. I’d like to run through a list of concerns that cancer patients have about vaccines in general and the COVID vaccine specifically.

So, let’s start with a basic question. Should people get vaccinated if they have cancer?

Dr. Roesch: 

Yes. All individuals diagnosed with cancer should get the COVID-19 vaccine as recommended by the National Comprehensive Cancer Network or NCCN.

An immunocompromised state makes many people with cancer at higher risk of serious COVID-19 illness. Those who are vaccinated are less likely to become sick with COVID-19. And, also, vaccinated people who do get COVID-19 are much less likely to become seriously ill.

I would also mention that those living in the same household as a person diagnosed with cancer and caregivers or other close contacts should also get vaccinated.

Katherine: 

Another common question is whether people with cancer should wait for any reason to get the COVID-19 vaccine.

Dr. Roesch: 

Most people with cancer should get the vaccine as soon as they can with a few exceptions according to NCCN.

People in the process of receiving stem cell transplant or cellular therapy should wait at least three months after they finish treatment to get vaccinated.

Those diagnosed with certain forms of leukemia should also wait a few weeks after receiving treatment to allow their immune system to recover so the vaccine can be effective.

It’s not been clearly defined exactly how chemotherapy affects responses to COVID-19 vaccines. But some data suggests that immune responses may not be as robust. However, it is still recommended that those receiving chemotherapy and also immunotherapy and radiation should get vaccinated whenever they can.

Katherine:

I think a lot of people are concerned too about whether one vaccine is better than another. What would you say to them?

Dr. Roesch:

And that is a common question that I often get in my clinic. And I advise my patients to receive or take whatever vaccine they are offered.

We don’t really have any studies or data at this point suggesting one being better than another in cancer patients.

Katherine: 

Some people are wondering if the vaccine can give a person COVID-19. How would you address that?

Dr. Roesch: 

I would say that as none of the currently available vaccines are made with a live virus, the vaccine itself can’t give a person COVID-19. By getting vaccinated, actually, those who are immunocompromised are really helping society to prevent the spread of COVID-19. Immunocompromised people who get COVID-19 may be more likely to infect others due to prolonged shedding of the virus after infection.

Katherine:

What about side effects? Are the vaccine’s side effects worse for people with cancer?

Dr. Roesch:  

No. Side effects do not appear to be worse for those diagnosed with cancer. Results to date suggest that the vaccine’s side effects in people with and without cancer are really no different.

These side effects, as we have seen, may include arm soreness, rash, fatigue, chills, fever, headache, for example.

Katherine: 

And, finally, can cancer patients stop wearing a mask after they’ve been vaccinated?

Dr. Roesch:

Cancer patients should continue to wear a mask post-vaccination. Many people with cancer may have a harder time actually fighting infections and may not respond as well to vaccines. So, people diagnosed with cancer and their close contacts should get vaccinated and then continue to follow precautions, which include wearing masks, social distancing, hand hygiene.

Katherine:

Is there a certain length of time that people need to continue wearing a mask after being vaccinated?

Dr. Roesch:  

At this time, I would recommend patients continue to follow the CDC guidelines that are currently in place. And at this point, I don’t think we have a projected end time for that yet.

Katherine:    

Is there anything else you’d like to share with cancer patients who may be concerned about vaccinations?

Dr. Roesch:    

I would encourage those diagnosed with cancer to not only themselves get vaccinated but to also really voice and stress the importance of vaccination to those that surround them, including, again, members of their household, close contacts, and even beyond their inner circle.

I would also advise people to try and avoid letting the concern of possible side effects related to the shot deter them from getting it. The symptoms of COVID-19 can be much worse and potentially serious for some compared with the relatively minor side effects that we’ve seen with the vaccine itself.

I also would mention I’ve had personal patients that have expressed concern about functioning of their immune system while receiving chemotherapy and how this might affect their response to the vaccine. I do emphasize to them that even though responses might not be as strong as they may be in the absence of active treatment, I feel like the potential benefits of the vaccine still outweigh the risks in my mind.

Katherine:   

Thanks so much for joining us today, Dr. Roesch.

Dr. Roesch:

Thank you for having me.

Is the COVID-19 Vaccine Safe for Myeloma Patients?

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Is the COVID-19 Vaccine Safe for Myeloma Patients? from Patient Empowerment Network on Vimeo.

 Should myeloma patients get the COVID-19 Vaccine? Dr. Joshua Richter encourages all patients to get the vaccine but notes important considerations around treatment.

Dr. Joshua Richter is director of Multiple Myeloma at the Blavatnik Family – Chelsea Medical Center at Mount Sinai. He also serves as Assistant Professor of Medicine in The Tisch Cancer Institute, Division of Hematology and Medical Oncology. Learn more about Dr. Richter, here.

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Transcript:

Katherine:

Is the COVID-19 vaccine safe for patients with myeloma?

Dr. Richter:

Absolutely, 100 percent yes. Everybody with myeloma should absolutely get the vaccine. What’s a little more complicated is the timing of it. So, one is in relation to stem cell transplant or CAR T-cell therapy. If you’ve had one of these, obviously, consult with your provider. But the general recommendation is to wait about 60 to 90 days after a high-dose therapy like that. And it’s not a question of safety, it’s a question of efficacy. Vaccines are like vegetables, seeds, you have to put them in the ground to grow. If you give yourself a vaccine right after a stem cell transplant, well, your bone marrow is not ready to work with it. It’s like planting a seed in the desert.

You want to make sure your immune system can take in that vaccine and give you immunity. So, you have to wait at least 60 to 90 days. The other question is, what happens if you’re getting continual therapy? And we don’t know the answer for most of these drugs, but one of the things is dexamethasone (Decadron), which is a steroid. Almost all myeloma therapy comes with some steroids. And we like to separate the vaccine from the steroid dose by a little bit if we can. Again, always important to talk with your care team as to risk/benefit about holding certain treatments.

COVID-19 Vaccination: What Do Breast Cancer Patients Need to Know?

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COVID-19 Vaccination: What Do Breast Cancer Patients Need to Know? from Patient Empowerment Network on Vimeo.

Is it safe to get the COVID-19 vaccine if you have breast cancer? Dr. Halle Moore of Cleveland Clinic provides valuable insight, including a discussion of side effects and the importance of staying up-to-date with visits and screenings.

Dr. Halle Moore is Director of Medical Breast Oncology at the Cleveland Clinic. Learn more about Dr. Moore, here.

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Transcript

Dr. Halle Moore:

For most adults with cancer or with a history of cancer, vaccination against COVID-19 with one of the newly approved vaccines is definitely recommended.

Common side effects after the COVID vaccinations are a sore arm, which is probably one of the most common side effects that we see. Fatigue and muscle aches can occur. Also, some patients will experience fever and chills, and that seems to be especially after the second dose of the vaccine. Rarely, severe allergic reactions can occur. And also, some people will experience enlargement of lymph nodes, typically in the underarm area or in the neck on the side of the vaccination.

This is particularly important for cancer patients to be aware of since enlarged lymph nodes could also be seen with cancer, and that might be alarming to some patients if they experience this side effect without knowing that that is a normal immune response to the vaccine.

In addition, cancer patients who are getting imaging, either a CAT scan or even a routine mammogram, if they get that imaging soon after the vaccine, the lymph nodes could be seen on imaging, and that might raise a concern as well. So, it’s important that patients let their provider know if they’ve had a recent vaccine and they’re getting any kind of imaging or mammogram.

So, breast cancer patients who are on chemotherapy or other treatments that could affect the immune system should definitely discuss with their oncology team the timing of vaccination with respect to their treatments.

This often needs to be individualized based on the planned duration of the cancer treatment as well as how much that treatment actually affects the immune system. In general, it is safe to get the vaccine during chemotherapy. It’s just that there may be a potential for reduced immune response during certain types of chemotherapy.

On the other hand, some chemotherapies are given more long term. And we don’t generally advise interrupting the chemotherapy for vaccination. So, oftentimes, we will recommend vaccination even in the setting of cancer treatment. Certainly, anti-estrogen treatments, hormonal treatments for breast cancer, or radiation treatment for the breast cancer should not alter either the safety or the effectiveness of these vaccines.

So, some of the ingredients in the various vaccinations that have led to these allergic reactions that we’ve heard about are also present in certain chemotherapy drugs. So, for people who have had a life-threatening reaction to chemotherapy, for instance, an anaphylactic reaction, it would be a good idea to discuss with your oncologist whether you should see an allergist prior to vaccination. This is something that we’re recommending for patients who’ve had severe allergic reactions to try to determine what component the reaction was to and whether vaccination with any of the individual vaccines might be safest.

Delaying care for non-COVID-related health concerns has been a major concern over the past year. It’s important for people to know that hospitals and medical clinics have numerous safety precautions in place. And we are really strongly encouraging everyone to continue to address all of their healthcare needs and to receive important treatments, particularly cancer treatments.

A New “New Normal”: COVID-19 Vaccine Guidelines and Cancer Patients 

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Editor’s Note: This blog was updated 1/31/22 to reflect current vaccine guidelines.

As we enter the 1-year mark of living in a pandemic, there have been a lot of changes in a world that has seemed stagnant, void of time. The inadequacies in healthcare that have been hiding behind the transparent curtain are now front and center, including health disparities, as well as access to and quality of care. We have also witnessed an influx of information about COVID-19 and the vaccine, and as cancer patients, it makes everything that much more complicated. 

Luckily, there are trusted resources we can turn to for guidance on our most pressing questions: 

What are the current vaccines? What age groups are eligible to receive them? 

  • Moderna: 18+ years old
  • Pfizer-BioNTech: 5+ years old
  • Janssen (Johnson & Johnson): 18+ years old

How many doses of each vaccine are given and how far apart? 

Moderna

  • Primary Dose: 2 shots, 28 days apart 
  • Booster Dose: Everyone ages 18 years and older should get a booster dose of either Pfizer-BioNTech or Moderna (COVID-19 vaccines) 5 months after the last dose in their primary series.

Pfizer-BioNTech:

  • Primary Dose: 2 shots, 21 days apart 
  • Booster Dose: Everyone ages 18 years and older should get a booster dose of either Pfizer-BioNTech or Moderna (COVID-19 vaccines) 5 months after the last dose in their primary series. Teens 12-17 years old should get a Pfizer-BioNTech COVID-19 Vaccine booster 5 months after the last dose in their primary series.

Janssen (Johnson & Johnson): 

  • Primary Dose: 1 shot
  • Booster Dose: Everyone ages 18 years and older should get a booster dose of either Pfizer-BioNTech or Moderna (mRNA COVID-19 vaccines) at least 2 months after the first dose of J&J/Janssen COVID-19 vaccine.  You may get J&J/Janssen in some situations.

If I am currently undergoing treatment, can I get the vaccine? 

Yes, as long as components of that vaccine are not contraindicated. Contraindications include: 

  • Severe allergic reaction after a previous dose of an mRNA or viral vector COVID-19 vaccine or any of its components 
  • Immediate allergic reaction of any severity to a previous dose of an mRNA COVID-19 vaccine (both Moderna and Pfizer-BioNTech) or any of its components 
  • Immediate allergic reaction of any severity to polysorbate
  • Immediate allergic reaction of any severity to any ingredient in the Janssen (Johnson & Johnson) vaccine such as polysorbate

If I am not currently undergoing treatment and still have cancer, can I get the vaccine? 

Yes, as long as components of that vaccine are not contraindicated. See contraindications above. 

If I no longer have cancer, should I get the vaccine? 

Yes, as long as components of that vaccine are not contraindicated. See contraindications above. 

Does it depend on when I get the vaccine based on what type of cancer I have/had? 

Yes, for guidelines on specific cancers, visit this link. 

Should my caregiver and/or people whom I live with also receive the vaccine? 

Yes, when the option becomes available to them. 

If I have previously had COVID-19 (tested positive), can I get the vaccine? 

Vaccination should be offered to persons regardless of history of prior symptomatic or asymptomatic COVID-19 infection. 

Am I fully protected after receiving the vaccine? 

At this time, researchers are unsure of how much protection the vaccine provides. Therefore, it is still recommended to wear a mask, wash yours hands for at least 20 seconds, and practice social distancing. 

However, vaccinated patients who are exposed to someone with suspected or confirmed COVID-19 aren’t required to quarantine if they: 

  • Are fully vaccinated (i.e., ≥ 2 weeks after receiving the second dose in a 2-dose series, or ≥ 2 weeks after receiving one dose of a single-dose vaccine) AND 
  • Are within 3 months after receiving the last dose in the series AND 
  • Have remained asymptomatic (without symptoms) since the current COVID-19 exposure 

What are common side effects of the vaccine and how long do they last? 

Side effects can include: 

  • Pain and swelling on the arm where you received the shot 
  • Fever, chills, fatigue, and headaches 
  • Most post-vaccination symptoms are mild to moderate in severity, occur within the first three days of vaccination, and resolve within 1–3 days 

Of course this list is non-exhaustive, and there are a lot more questions to be asked and more answers to be found as frontline workers continue to study the virus and its variants. For the latest updates, follow the Centers for Disease Control and Prevention (CDC) website, as well as American Society of Clinical Oncology (ASCO) and the National Comprehensive Cancer Network (NCCN). We’re in this together, one day at a time. 

Sources:  

  1. https://www.ama-assn.org/system/files/2020-12/covid-19-vaccine-patient-faqs.pdf 
  2. https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html
  3. https://www.onclive.com/view/nccn-releases-covid-19-vaccination-guidance-for-patients-with-cancer 

Cancer-Specific Resources:

  1. Is the COVID-19 Vaccine Safe for Myeloma Patients?
  2. What AML Patients Should Know About the COVID-19 Vaccines
  3. COVID-19 Vaccination: What Do Myelofibrosis Patients Need to Know?
  4. COVID-19 Vaccination: What Do Breast Cancer Patients Need to Know?