OncologyTube.com is the first and only free video sharing website dedicated to helping oncology professionals spread knowledge about cancer research through video, audio and other multimedia.
    • OncologyTube Cancer Articles, News and Videos

      Site: OncologyTube Cancer Articles, News and Videos

    • 0
      • Portuguese
      • Spanish
      • Italian
      • Greek (Greece)
      • Sinhala
      • Polish
      • Arabic (Saudi Arabia)
      • Swedish (Sweden)
      • Portuguese (Brazil)
      • Hindi (India)
      • English (Australia)
      • Hebrew (Israel)
      • Czech
      • Hungarian (Hungary)
      • Chinese
      • Turkish
      • Japanese (Japan)
      • Dutch
      • French
      • German
      • Chinese (Traditional Han, Taiwan)
      • Korean (South Korea)
      • Thai
      • Spanish (Chile)
      • English (United States)
      • Russian
      • Danish (Denmark)
  • Home
  • Trending

  • Login

  • Quick Links
  • How To Self Record An Interview and Presentations
  • Schedule A Remote Interview!
  • Check Out Our Blog
  • Buy Advertising Banners
  • Buy Pre-Roll Advertisements
  • Boost Your Earned Media starting at Just $60
  • Create A Deep Dive Conversation
  • Advertising Specifications
  • Our Editorial Process
  • Publisher Calendar

  • Products & Pricing
  • Banner Advertising Plans
  • eNewsletter Packages
  • Pre-Roll Advertising
  • Create A Deep Dive Conversation
  • Create a Video Release (VR)
  • Boost Earned Media Only $60

  • Mobile
  • Connect Mobile App

  • Audio and Video
  • Videos
  • Audio

  • Channels
  • Browse Channels

  • Categories
  • Acute Lymphoblastic Leukemia 5595
  • Acute Myelogenous Leukemia 226
  • Bladder 96
  • Bone Metastases 5
  • Brain 79
  • Breast 562
  • Business Management 5
  • Cervical 16
  • Chronic Lymphocytic Leukemia 209
  • Chronic Myelogenous Leukemia 54
  • Colorectal 172
  • Conference Coverage 1
  • COVID-19 43
  • Gastrointestinal 177
  • General 341
  • Genitourinary 3
  • Head and Neck 110
  • Help 3
  • Hematologic Malignancies 206
  • Hodgkin Lymphoma 34
  • Imaging 2
  • Immunotherapy 179
  • Kidney 392
  • Liver 40
  • Lung 95
  • Lymphoma 235
  • Melanoma and Skin 107
  • Multiple Myeloma 535
  • Myeloproliferative Disease 37
  • News 149
  • Non-Hodgkin Lymphoma 81
  • Non-Small Cell Lung Cancer 554
  • Other 517
  • Ovarian 65
  • Pancreatic 104
  • Patient Resources 51
  • Pediatric 7
  • Prostate 300
  • Sarcoma 13
  • Sickle Cell 22
  • Small Cell Lung Cancer 81
  • Supportive Care 51
  • Testicular 3
  • Urology 16
  • Uterine 9

  • Install
  • Play a Link
  • About
  • Contact
  • Acute Lymphoblastic Leukemia
  • Acute Myelogenous Leukemia
  • Bladder
  • Bone Metastases
  • Brain
  • Breast
  • Business Management
  • Cervical
  • Chronic Lymphocytic Leukemia
  • Chronic Myelogenous Leukemia
  • Colorectal
  • Conference Coverage
  • COVID-19
  • Gastrointestinal
  • General
  • Genitourinary
  • Head and Neck
  • Help
  • Hematologic Malignancies
  • Hodgkin Lymphoma
  • Imaging
  • Immunotherapy
  • Kidney
  • Liver
  • Lung
  • Lymphoma
  • Melanoma and Skin
  • Multiple Myeloma
  • Myeloproliferative Disease
  • News
  • Non-Hodgkin Lymphoma
  • Non-Small Cell Lung Cancer
  • Other
  • Ovarian
  • Pancreatic
  • Patient Resources
  • Pediatric
  • Prostate
  • Sarcoma
  • Sickle Cell
  • Small Cell Lung Cancer
  • Supportive Care
  • Testicular
  • Urology
  • Uterine
Navitoclax: ASH 2022 Jalaja Potluri Disease Modification in Myelofibrosis
0:07:51

Navitoclax: ASH 2022 Jalaja Potluri Disease Modification ...

Navitoclax: ASH 2022 Jalaja Potluri Disease Modification in Myelofibrosis

By Jalaja Potluri, MD

How can this study help modify myelofibrosis? Navitoclax is the investigational drug, which is not currently approved. It is being studied in a condition called Myelofibrosis. It's a bone marrow disease where there's changes in the blood counts and patients are symptomatic, with enlarged spleen. It is being studied in a phase 2 program, and the data that are being discussed are from this ongoing phase II study. It has multiple cohorts. The data that was just presented represents a population that has not yet received the current standard of care Ruxolitinib, and we're combining Navitoclax the investigational agent with the standard of care Ruxolitinib.

 

What is the current standard of care in patients with myelofibrosis and why the Navitoclax clinical trial matters?  

The current standard of care is with what we call JAK inhibitors, and they have been the standard of care with the approval of Ruxolitinib in 2011. It's an oral drug that's taken twice daily and it controls improvement in spleen size and symptoms of the patient, which are. The general presentations for patients with this disease and what's important for this combination is while patients do benefit, majority of them do benefit from improvement in their symptoms and the size of their spleen.

 

This combination, it not only increases the these responses, but also has more in-depth response, meaning some of the things that we're noticing could impact the natural history of the disease. By that, what we call it as potentially disease modifying trying to control some of the hallmarks of the disease, meaning the fibrosis and the bone marrow, improving their blood counts, and also trying to suppress some of the genetic abnormalities that are seen in association with this disease. So that's why we're excited with the combination, improve upon the current standard of care.

 

What is the Navitoclax trial design and why was it set up this way?  

This is a phase 2 study, it was developed to understand how this combination would work in patients. We did have some preclinical data that supported that the two agents can be synergistic and therefore the Navitoclax trial was begun in patients who already received the standard of care Ruxolitinib. So we added Navitoclax in the earlier cohort of 34 patients, and we presented that data and there's a publication as well, and once we had the data that were very encouraging, we expanded the trial into different cohorts and we have shared those data in patients who had add-on Navitoclax to an ongoing Ruxolitinib. And also now this particular cohort is looking at patients who have not yet received the current standard of care, but starting both of these medications at the same time that we're calling it as JAK inhibitor naive population.

 

What are some significant data and statistics for the Navitoclax trial?  

Ruxolitinib, the pivotal or the registration trial showed patients who have improvement in spleen in about 40% of the patients, and the similar number of patients had improvement in their symptoms, which are very key for patients who experienced this disease. What we have seen in this cohort of patients in this phase 2 study are about 60% of the patients are having that improvement in the spleen, and about 40% of the patients have improvement in their symptoms.

 

What's exciting now is not only there's incremental improvement in the spleen with this combination, we're also seeing what I just mentioned regarding, the potential disease modification with improvement in that bone marrow change is called marrow fibrosis grade. So we're seeing improvement in the marrow fibrosis grade in about a third of the patients.

 

So we're very excited that this potentially could help alter the natural history of the disease. And that's the exciting data that we have shown and it's seen across the board, regardless of which type of prognostic group of patients are enrolled and have received this combination. It's a small sample size, but we're excited with the emerging data that we have.

 

Read and Share the Article Here: https://oncologytube.com/v/41589

Listen and Share the Audio Podcast Here: https://oncologytube.com/v/41590

 

What are Navitoclax and Ruxolitinib?

Navitoclax:

It is a synthetic, orally accessible, small-molecule antagonist of a subset of the B-cell leukemia 2 (Bcl-2) protein family with potential antitumor efficacy. ABT-263 binds specifically to apoptosis suppressor proteins Bcl-2, Bcl-XL, and Bcl-w and blocks their binding to the apoptotic effectors Bax and Bak proteins, which may induce apoptosis in tumor cells overexpressing Bcl-2, Bcl-XL, and Bcl-w. Bcl-2, Bcl-XL, and Bcl-w are widely overexpressed in numerous malignancies, including those of the lymphatic system, breast, lung, prostate, and colon, and have been associated with tumor therapeutic resistance.

Ruxolitinib:

Is a treatment for myelofibrosis (is a cancer of the bone marrow in which the bone marrow is replaced by scar tissue and causes decreased blood cell production). It is also used to treat polycythemia vera (PV; a slow-growing blood malignancy in which the bone marrow produces too many red blood cells) in patients who did not respond to hydroxyurea. Ruxolitinib is also used to treat acute graft versus host disease (aGVHD; a complication of hematopoietic stem-cell transplant [HSCT; a procedure that replaces diseased bone marrow with healthy bone marrow] that typically develops within the first few months after HSCT) in adults and children 12 years and older who were treated unsuccessfully with corticosteroid medications. It is also used to treat chronic GVHD (cGVHD; a consequence of HSCT that typically arises at least 3 months after HSCT) in adults and children 12 and older who have been unsuccessfully treated with one or two prior treatments. Ruxolitinib belongs to the class of drugs known as kinase inhibitors. It treats myelofibrosis and PV by inhibiting the impulses that promote the multiplication of cancer cells. This prevents the spread of cancerous cells. It treats GVHD by inhibiting the signaling of the cells responsible for GVHD.

 

Did the Navitoclax trial have a primary end point. And was it met?  

The Navitoclax study is a phase 2 trial the primary endpoint is spleen volume reduction. And this is unlike a registration or a phase 3 trial. This is not a trial where we would have a study designed to meet its statistical significance. Therefore, I would say the objective has been met, but I can't say that there is a statistical significance. The data are definitely very compelling compared to the historic data. We can't compare cross trial, but, based on the available data from the pivotal Ruxolitinib trials, and what we're seeing in our combination is definitely we think that the clinical study has met the objective, but in terms of did it meet the endpoint will be determined in later more randomized clinical trials.

 

What are the most common questions asked by your colleagues for this research?  

When you add new drugs we have to think about their tolerability and how long can they receive the drug and what incremental benefit they might receive. More importantly in terms of the incremental benefit, definitely it's a 60% and higher response rates At week 24 is when we measure. The outcome of the spleen volume in this particular disease.

 

When we leave patients to continue to receive the drug, we're seeing improvement in that spleen volume upwards of 70%. So that's very encouraging, compared to what has been published that we know of for Ruxolitinib, and that's the data that we share with our oncology colleagues. The second thing is the safety. This is a drug called BCL-XL inhibitor, and that's a, based on its mechanistic mechanism of action. It does target certain blood cells, so it does lead to what we call thrombocytopenia or decrease in platelets. It's a common signal and it is something that we do want physicians to be careful, monitor the patients more closely.

So that's a safety aspect that we continue to remind all of our investigators that are participating in the Navitoclax trial. One thing to note is, it is very well tolerated with all the modifications of the dosing that we implement into the trial and without any problems to the patients. It's the numerically, the numbers, do drop, but they're well managed with the dose adjustments. So those are the key things that we communicate with our investigators.

 

What are the key takeaways from the Navitoclax clinical investigation?  

I am a hematologist myself, I'm very excited for a lot of new innovative targeted therapies for patients with a lot of these chronic but very debilitating conditions. And so there's a lot of signs that's advancing in myelofibrosis, and I think the patients do, deserve better. We need to improve upon their outcomes. So looking forward to advancing the science and being part of this development of Navitoclax in combination treatment with Ruxolitinib. 

 

Jalaja Potluri, MD - About The Author, Credentials, and Affiliations

Dr. Jalaja Potluri is a board-certified hematologist and oncologist who has worked in the pharmaceutical industry for over 15 years. She has experience in both clinical practice and cancer research thanks to her participation in national cooperative cancer clinical trials. Extensive expertise in the pharmaceutical industry is required for the design, development, and execution of Phase 1 to 3 clinical trials, including the approval of new medications for a variety of indications on a global scale. She currently holds the position of Executive Medical Director at AbbVie.

 

Reference

  1. NIH - Navitoclax. NIH, 2022

  2. Medline Plus - Ruxolitinib. Medline Plus, December 15, 2021

 

 

931 Views
2 months Ago
ASH
Add to
Want to watch this again later?
Sign in to add this video to a playlist. Login

Myeloproliferative Disease

Navitoclax: ASH 2022 Jalaja Potluri Disease Modification in Myelofibrosis
0:07:21
Navitoclax: ASH 2022 Jalaja Potluri Disease Modification ...
11 Views
2 months Ago
ASH
Add to
Want to watch this again later?
Sign in to add this video to a playlist. Login
Navitoclax: ASH 2022 Jalaja Potluri Disease Modification in Myelofibrosis
Navitoclax: ASH 2022 Jalaja Potluri Disease Modification ...
10 Views
2 months Ago
ASH
Add to
Want to watch this again later?
Sign in to add this video to a playlist. Login
Navitoclax: ASH 2022 Jalaja Potluri Disease Modification in Myelofibrosis
0:07:51
Navitoclax: ASH 2022 Jalaja Potluri Disease Modification ...
931 Views
2 months Ago
ASH
Add to
Want to watch this again later?
Sign in to add this video to a playlist. Login
IPSS: ASH 2022 Roger Lyons Treatment Pattern and Overall Survival MDS
0:05:55
IPSS: ASH 2022 Roger Lyons Treatment Pattern and Overall ...
8 Views
2 months Ago
ASH
Add to
Want to watch this again later?
Sign in to add this video to a playlist. Login
IPSS: ASH 2022 Roger Lyons Treatment Pattern and Overall Survival MDS
IPSS: ASH 2022 Roger Lyons Treatment Pattern and Overall ...
31 Views
2 months Ago
ASH
Add to
Want to watch this again later?
Sign in to add this video to a playlist. Login
IPSS: ASH 2022 Roger Lyons Treatment Pattern and Overall Survival MDS
0:06:50
IPSS: ASH 2022 Roger Lyons Treatment Pattern and Overall ...
612 Views
2 months Ago
ASH
Add to
Want to watch this again later?
Sign in to add this video to a playlist. Login
Pacritinib: Phase 3 PACIFICA Trial Dr. Mascarenhas ASH 2022
Pacritinib: Phase 3 PACIFICA Trial Dr. Mascarenhas ASH 2022
28 Views
3 months Ago
ASH
Add to
Want to watch this again later?
Sign in to add this video to a playlist. Login
Pacritinib: Phase 3 PACIFICA Trial Dr. Mascarenhas ASH 2022
0:11:12
Pacritinib: Phase 3 PACIFICA Trial Dr. Mascarenhas ASH 2022
534 Views
3 months Ago
ASH
Add to
Want to watch this again later?
Sign in to add this video to a playlist. Login
Momelotinib: Update On MOMENTUM Trial Dr. Gerds ASH 2022
Momelotinib: Update On MOMENTUM Trial Dr. Gerds ASH 2022
66 Views
3 months Ago
ASH
Add to
Want to watch this again later?
Sign in to add this video to a playlist. Login
Momelotinib: Update On MOMENTUM Trial Dr. Gerds ASH 2022
0:08:39
Momelotinib: Update On MOMENTUM Trial Dr. Gerds ASH 2022
122 Views
3 months Ago
ASH
Add to
Want to watch this again later?
Sign in to add this video to a playlist. Login
Clonal Hematopoiesis: Myeloid Malignancy Prediction - Weeks, MD ASH 2022
Clonal Hematopoiesis: Myeloid Malignancy Prediction - Wee...
29 Views
3 months Ago
ASH
Add to
Want to watch this again later?
Sign in to add this video to a playlist. Login
Clonal Hematopoiesis: Myeloid Malignancy Prediction - Weeks, MD ASH 2022
0:08:14
Clonal Hematopoiesis: Myeloid Malignancy Prediction - Wee...
45 Views
3 months Ago
ASH
Add to
Want to watch this again later?
Sign in to add this video to a playlist. Login

comments@oncologytube.com Copyright 2023 Medicus Networks, Inc. 45121 Morgan Heights Rd. Temecula, CA 92592 - (951) 326-8827