GRACE :: Lung Cancer

first line therapy

Denise Brock

Lung Cancer Video Library – Evolving Options in First Line Treatment of ALK-Positive Non-Small Cell Lung Cancer (NSCLC)

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GRACE Cancer Video Library - Lung

 

 

We welcome Dr. Luis Raez, MD FACP FCCP, Chief of Hematology/Oncology and Medical Director at Memorial Cancer Institute, and Clinical Associate Professor of Medicine at Florida International University with 2017 updates to our Lung Cancer Video Library.  In this recent video for GRACE, Dr. Raez discusses Evolving Options in First Line Treatment of ALK-Positive Non-Small Cell Lung Cancer (NSCLC).


 

 

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 Dr. Luis Raez, MD FACP FCCP

Chief of Hematology/Oncology and Medical Director, Memorial Cancer Institute
Clinical Associate Professor of Medicine, Florida International University
 

 

 


  


Denise Brock

Lung Cancer Video Library – First Line Combinations, Immunotherapy with Chemo

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GRACE Cancer Video Library - Lung

 

 

We welcome Dr. Luis Raez, MD FACP FCCP, Chief of Hematology/Oncology and Medical Director at Memorial Cancer Institute, and Clinical Associate Professor of Medicine at Florida International University with 2017 updates to our Lung Cancer Video Library.  In this recent video for GRACE, Dr. Raez discusses First Line Combinations, Immunotherapy with Chemotherapy.


 

 

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 Dr. Luis Raez, MD FACP FCCP

Chief of Hematology/Oncology and Medical Director, Memorial Cancer Institute
Clinical Associate Professor of Medicine, Florida International University
 

The FDA recently approved Pembrolizumab in combination with chemotherapy for new patients with stage IV or metastatic non-small cell lung cancer.  This important breakthrough is based on a small study, a randomized phase II study, presented by Merck that basically shows that there is a benefit of adding the immunotherapy agent Pembrolizumab to the conventional chemotherapy carboplatin base.  This is very important because, until three weeks ago, the only way a patient could get immunotherapy in the front line was if he was able to have the PD-L1 marker expression in the tumor more than 50%.  So that was the only approval for immunotherapy as a single agent for new patients.  Since the approval now, the patient not only can have Pembrolizumab but can also have chemotherapy at the same time with the idea to improve response rate and progression-free survival.  So this is a very important landmark approval but it is not based on a phase III randomized study so this approval has to be verified as a condition to a phase III study that is ongoing that needs to be finished and the results presented to see if this combination of Pembrolizumab with chemotherapy is going to be our new standard of care.  That is why it is not embraced by all the doctors yet.  The other important thing to remember is that, in this approval given by the FDA, patients do not have to the 50% staining of their tumors with the marker PD-L1. If you will remember, I said at the beginning, if you want to have Pembrolizumab as a single agent as a new patient, you have to stain more than 50% of your tumor with the PD-L1.  If you are going to use now  Pembrolizumab with chemotherapy we don’t need the stain.  It is approved now for people that have a higher stain of more than 50% and for people who have less stain, less the 49 or 50%.  That is a very important difference.  The other thing is we already have six other immunotherapy agents in development, at least, and we have a lot of expectation waiting to know what is going to happen with the other immunotherapy agents and, hopefully, some of them will be able to be more in the front line. 


  


Denise Brock

Lung Cancer Video Library – Spanish Language: Video #26 Integrating Immune Checkpoint Inhibitors Into First-Line Therapy for Advanced NSCLC

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GRACE Cancer Video Library - Lung

 

We continue to provide informational videos for our Spanish speaking community and welcome Dr. Luis Raez, MD FACP FCCP, Chief of Hematology/Oncology and Medical Director at Memorial Cancer Institute, and Clinical Associate Professor of Medicine at Florida International University.  Dr. Raez joined GRACE to discuss the basics of lung cancer.  In this 26th video for the Spanish lung cancer video library, Dr. Raez discusses integrating immune checkpoint inhibitors into first-line therapy for advanced NSCLC.


 

 

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Integrando los inhibidores de los puntos de control inmunológicos en la terapia de primera línea para el cancer pulmonar avanzado de células no pequeñas

¿Cuál es el futuro de la inmunoterapia? Sabemos que la inmunoterapia está aprobada para segunda línea y que probablemente es nuestro fármaco favorito de segunda línea. Pero obviamente, todos queremos ver ese beneficio en primera línea, pero en primera línea tenemos evidencia sólida que la quimioterapia con bevacizumab para carcinomas o que la terapia con necitimumab para carcinomas de células epidermoide o escamosas, están bien establecidas.

Entonces las opciones que tenemos hoy en día, en base a los estudios con los 7 agentes inmunoterapeuticos disponibles para tratar de ver si lo mejor vas a ser reemplazar a la quimioterapia en primera línea, o si lo mejor va a ser añadir la inmunoterapia en primera línea. Esas dos opciones se están explorando para ver en cuál de los casos se van a hacer. A veces, la solución para poner quimioterapia en primera línea, es escoger que pacientes van a responder a la inmunoterapia y a ellos darles inmunoterapia de primera línea como hacemos con las terapia blanco en donde como vimos seleccionamos quienes son EGFR o ALK y a esos les damos la terapia blanco y al resto les damos la quimioterapia.

Esa es la solución, separar a los pacientes que van a responder de los que no y de esa forma ver a quien le damos inmunoterapia y quien le damos quimioterapia.

El único problema que tenemos, como ustedes saben, es que el marcador PDL1 no es un todavía un marcador estándar por lo que no hay todavía consenso de que sea la mejor forma para discriminar a quien se le da inmunoterapia y a quien no, por esa razón todavía hay mucho por hacer.


Integrating the immunological checkpoint inhibitors in the first line therapy for non-small cell lung cancer in advanced stage

What is the future of immunotherapy? We know that immunotherapy is approved for second line treatments and that it is probably our favorite drug in second line. But obviously, we all want to see this benefit in first line. However, in first line we have solid evidence that chemotherapy with bevacizumab or necitimumab for epidermoid carcinomas are well stablished.

Then the options we have, based on the 7 immunotherapeutic agents available, is to decide if it’s better to substitute chemotherapy in first line or to add immunotherapy to first line. In this two options, several cases are being studied to see which one works best. Sometimes the solution for first line chemotherapy is choosing what patients are going to respond to immunotherapy and give them first line immunotherapy as we do in targeted treatments with EGFR or ALK positive patients and the rest we give them chemotherapy.

That is the solution, separating the patients that are going to respond from the ones that are not and see who we can give immunotherapy and the ones we have to give chemotherapy.

The only problem we have, is as you know, PDL1 marker is not and standardized marker yet so we don’t have a consensus that it is the best way to discriminate who gets immunotherapy and who doesn’t. For that reason, we still have a lot to do.


GRACE Video

Immunotherapy for First Line Therapy of Advanced NSCLC

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GRACE Cancer Video Library - Lung

GCVL_LU-FE09_Immunotherapy_First_Line_Therapy_Advanced_NSCLC

 

Dr. Eddie Garon considers the data on immunotherapies for first line treatment of advanced NSCLC and whether we are likely to use these agents instead of or in combination with standard chemotherapy soon.

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So, initially, development of the PD-1 and PD-L1 inhibitors were in patients who were previously treated, as that is a very difficult clinical scenario. Now, we do know, in the front line setting, that there is data that would indicate that many patients do quite well with chemotherapy, certainly not all, and the toxicities are certainly there, but chemotherapy can be quite effective in patients with non-small cell lung cancer. So, the question when you have a drug that is as effective, or a class of drugs that are as effective, as the PD-1 and PD-L1 inhibitors in previously treated non-small cell lung cancer, is: can those results be moved forward — can patients receive this as their initial therapy, rather than traditional chemotherapy approaches?

This is a place where, in my estimation, evaluation of the biomarker is going to be particularly important. So, there is data that would indicate patients who have higher degrees of staining for PD-L1 are more likely to respond to these immune checkpoint inhibitors. Of course, there is other biomarker work that is underway as well, some of which has been published, and some of which continues to go on, that may also be very helpful in identifying the appropriate set of patients. But, when one is looking at front line checkpoint inhibitors, one has to realize that, if you can identify a group of patients that are unlikely to have a response to a checkpoint inhibitor, that group of patients, probably, would be better off receiving standard chemotherapy in the front line setting, which we know can be quite effective, and, therefore, most of the studies that are looking at front line therapy are selecting patients who have, for instance, high level expression of PD-L1, and that has been, certainly, a major focus — people have taken different approaches. There are some studies that are specifically identifying patients, and only randomizing patients who have a high degree of staining to chemotherapy or a checkpoint inhibitor in the front line setting. Others are enrolling patients more broadly, but limiting their analysis to the patients who have a high degree of staining.

What I will say is, as somebody who has, for instance, studies in the front line setting that would give everyone a checkpoint inhibitor, as well as studies in the front line settings that would give only selected patients a checkpoint inhibitor, I have been very reluctant, at this point, with the data we have available, to enroll patients on a front line checkpoint inhibitor without knowing their PD-L1 status, because my concern is that, although you can say, well, those patients could always get chemotherapy later, we know that some patients with non-small cell lung cancer don’t get to their second treatment, and, in fact, that is not an uncommon scenario. We know, as well, that it does take some time for these checkpoint inhibitors to be effective in many of the patients in whom they are effective.

So, I have some concerns — for instance, if a patient has low level staining, although we don’t have all of the data yet, my suspicion is that, for instance, a patient with absent PD-L1 staining would probably be better off getting standard chemotherapy in the front line setting, and I think that it’s an important thing for patients to know, and of course the clinical data will sort of lead us there, but it is not clear that this is the absolute best therapy for everyone at every time. I think that there is a group of patients for whom that is likely to be the case — the group of patients in the KeyNote 001 study, which was looking at Keytruda, where they had not previously been treated — the survival in that group was so impressive, in fact, that we couldn’t even report on the bottom limit of the 95% confidence interval for survival, because patients just were staying on, they weren’t dying, of the people who had high level staining. That being said, the people who had absent staining — they didn’t do as well, and that’s a group of people, where my suspicion is, would do better with chemotherapy. We will see when the clinical data comes out.


GRACE Video

Clinical Trials of Immune Checkpoint Inhibitors as First Line Therapy for Advanced NSCLC

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LCAM 2015

 

Dr. Jack West summarizes the rationale for testing immune checkpoint inhibitors as a first line treatment for patients with advanced NSCLC and highlights details of two trials testing this question.

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