Experimental Therapeutics
March 01, 2021Information
February 28, 2021
Yale Cancer Center
visit: http://www.yalecancercenter.org
email: canceranswers@yale.edu
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- 00:00Support for Yale Cancer Answers
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- 00:10More information at astrazeneca-us.com.
- 00:14Welcome to Yale Cancer Answers
- 00:16with your host doctor
- 00:17Anees Chagpar. Yale Cancer Answers
- 00:20features the latest information on
- 00:22cancer care by welcoming oncologists and
- 00:24specialists who are on the forefront of
- 00:26the battle to fight cancer. This week,
- 00:28it's a conversation about experimental
- 00:30therapeutics with Doctor Pat LoRusso.
- 00:32Doctor LoRusso is a professor of
- 00:34medicine at the Yale School of Medicine,
- 00:37where Doctor Chagpar is a professor
- 00:40of surgical oncology.
- 00:41Pat,
- 00:42maybe we can start off by you telling
- 00:44us a little bit more about what
- 00:48exactly is experimental therapeutics.
- 00:50It sounds so obscure and
- 00:52intellectual and scientific and strange.
- 00:55It isn't obscure for
- 00:56me. I think it is somewhat intellectual,
- 00:59and it is very scientific,
- 01:01and so I hope that I'll be able to
- 01:05explain to you what all that means.
- 01:08So with every cancer drug that we have,
- 01:12that we treat patients for, every cancer
- 01:14drug that's commercially available,
- 01:16it has to go through a series of testing not
- 01:20only in the lab to identify its activity,
- 01:23not only in other animal species,
- 01:26to make sure that it is safe
- 01:28to administer to humans,
- 01:30which are called toxicology studies,
- 01:32but then it has to go through a series
- 01:35of tests in humans first to make
- 01:38sure that the drug is safe to give,
- 01:42and then to find
- 01:45out how active it is,
- 01:47either alone or in combination
- 01:50with other agents.
- 01:52So Phase one clinical trials
- 01:55are essentially trials
- 01:58whereby a new drug is tested
- 02:01for the first time in humans.
- 02:06Although the primary objective of a
- 02:09phase one trial is actually to make sure
- 02:12that the drug is safe to give to humans.
- 02:15We are also looking for a lot
- 02:18of other endpoints as well.
- 02:20What kind of activity does it have
- 02:24against specific tumor types?
- 02:26How is the exposure of the drug
- 02:28in man relative to what we saw
- 02:32previously in various animal species
- 02:34and to assure that we have the
- 02:37utmost safety in these trials.
- 02:39Obviously all trials have to be approved
- 02:42by the Food and Drug Administration
- 02:45before they can be initiated in humans,
- 02:48and that is the same thing with a
- 02:51phase one or first in human study.
- 02:54But what they do
- 02:56is based on animal trials previously
- 02:59done with the agent and toxicology
- 03:02studies that are also previously done.
- 03:05The FDA works with the sponsor
- 03:08or the drug company to identify
- 03:11a safe starting dose.
- 03:13A dose where we can feel quite
- 03:17assured that giving that dose will
- 03:20be safe to humans and to identify
- 03:23what the most relevant dose will be
- 03:27to go into subsequent phase two and
- 03:30three trials and then hopefully to
- 03:33go into FDA approvals for standard
- 03:36of care treatment.
- 03:38We do various escalation steps along
- 03:40the way to identify a safe dose that
- 03:45can be subsequently brought into a phase
- 03:48two efficacy or a phase
- 03:50two comparative efficacy study
- 03:52which may take anywhere from 3 to
- 03:5510 or 12 escalation steps.
- 03:58So that we're gradually increasing
- 04:00the dose to the point where we
- 04:03identify what a safe dose is that can
- 04:06be subsequently advanced to other
- 04:09phases of clinical trial development.
- 04:15So this is really important work,
- 04:18because this is how we get the drugs into
- 04:22the clinics that actually provide the
- 04:25cures that all of us want for cancer.
- 04:29But it really starts very much in the lab,
- 04:33so help me to understand and
- 04:36help our listeners to understand
- 04:38what goes into
- 04:42getting a drug even into phase one
- 04:44because as you describe it Phase
- 04:47one clinical trials maybe seem
- 04:49really scary to a lot of patients.
- 04:51I mean this concept of being
- 04:53quote first in man.
- 04:54Many people are thinking
- 04:57why would I want to be the first
- 04:59ones for you to experiment and
- 05:01see what is safe and what is
- 05:04tolerable and what is efficacious?
- 05:06So let's take a step back before that
- 05:09and kind of lay the groundwork for me
- 05:12in terms of what goes on before that.
- 05:14How do we get
- 05:16to the point of a phase one trial
- 05:19where you're presenting data to
- 05:22the FDA?
- 05:26First a drug is developed in the lab based on a
- 05:30scientific principle or a scientific concept.
- 05:33So I think the best way to describe
- 05:37it would be to use an example.
- 05:40So in many tumor types,
- 05:42primarily non small cell lung
- 05:45cancer and colorectal cancer,
- 05:46but other tumors as well,
- 05:49there is a mutation called KRAS G12C.
- 05:53And that mutation in large part drives that
- 05:56tumor and makes it extremely aggressive.
- 05:59It's taken many, many,
- 06:01many years for chemists to develop a
- 06:05drug that can target or inhibit that
- 06:09mutation from continuing to allow
- 06:13the tumor to multiply and divide.
- 06:17So that drug probably
- 06:19took about 20 years conservatively of
- 06:22chemists working on trying to figure
- 06:24out how to target that mutation,
- 06:27which was extremely difficult
- 06:29because of the way that mutation is
- 06:32pocketed in the DNA of the tumor.
- 06:35Once they identify a compound that can
- 06:39bind to that mutation
- 06:41or attack that mutation,
- 06:43then they have to test it
- 06:45in animal models,
- 06:46tumors in animals that have that
- 06:49mutation to see whether or not the drug
- 06:52is going to work against those tumors
- 06:54inhibit those tumors from growing,
- 06:57preventing those tumors in animals from
- 06:59metastasizing or going beyond where
- 07:02the tumor was originally implanted.
- 07:05Once they do that,
- 07:06and identify that the drug is active,
- 07:09then we have to take it into
- 07:11toxicology studies where we test the
- 07:14drug in different animal species
- 07:16to make sure that
- 07:18we can safely give
- 07:20that drug to the animals without
- 07:23causing side effects or harms,
- 07:25and we usually have to do that in two
- 07:28or three different animal species,
- 07:30depending on what the drug is.
- 07:32But back in the olden days I call
- 07:35it when I first started doing
- 07:37clinical drug development,
- 07:39during development of drugs in humans,
- 07:42we didn't have the scientific
- 07:44basis that we have today and today
- 07:48there's a lot of science that is
- 07:51driving new drug
- 07:54discoveries in the lab,
- 07:56especially with targeted drugs
- 07:58because of the fact that unveiling
- 08:01the human genome several years ago
- 08:04allowed us to better understand the
- 08:07differences between the DNA and RNA.
- 08:10In tumors versus the DNA and RNA in
- 08:13the normal human and what we had to
- 08:16go after in those tumors to prevent
- 08:19them from growing and hopefully from
- 08:22prevent them eventually from even coming
- 08:25about in patients that may be high risk,
- 08:28such as in prevention,
- 08:29but no matter where the drug ends
- 08:32up treating advanced stage patients,
- 08:35patients that have cancer
- 08:36that's metastasized,
- 08:37or patients that have had cancer,
- 08:40but we've removed the tumor.
- 08:42And we want to prevent the
- 08:45cancer from coming back.
- 08:46Every drug that's given to humans in
- 08:49a general oncology office has to at
- 08:52first be tested in early phase clinical
- 08:55trials and back in the olden days.
- 08:58You know,
- 08:59we tested a lot of drugs based
- 09:02on just these high throughput
- 09:04screens in mouse models without a
- 09:07lot of science, there was science there,
- 09:10but today, in 2021 the science
- 09:13has advanced much more
- 09:15that we are even selecting
- 09:17out certain tumor types.
- 09:19Patients that have certain types
- 09:21of cancers based on the science.
- 09:24Because we know even in phase one
- 09:26trials that we may have a greater
- 09:29chance of response and benefit if we
- 09:33only treat patients with those tumors.
- 09:35Going back to the KRAS G12C mutation
- 09:39that I was talking about a few minutes ago,
- 09:43we only included in those phase one trials
- 09:46patients that we knew whose
- 09:50tumors had that mutation and in non
- 09:53small cell lung cancer in a phase one
- 09:57trial we were seeing close to 70-75%
- 10:00tumor response and in colon cancer,
- 10:03in patients who had colon cancer
- 10:06that had the KRAS G12 C mutation,
- 10:09we were seeing responses about 40 to
- 10:1350% and many of those patients had a
- 10:16lot of prior treatments either immunotherapy,
- 10:20chemotherapy,
- 10:21or both and yet despite having all those
- 10:25different cancers be treatments because
- 10:27their cancers had that one mutation,
- 10:30there was significant benefit as early
- 10:33as in the Phase one clinical trial.
- 10:37So even though these trials
- 10:39are primarily toxicity
- 10:41finding studies and finding
- 10:43the recommended phase two dose
- 10:46many times in these trials,
- 10:48if we have a specific target that
- 10:51we're targeting and we can identify
- 10:55patients whose tumors have that target,
- 10:58there is a potential therapeutic
- 11:00benefit for those patients
- 11:03either in terms of their tumors
- 11:05shrinking or staying stable for
- 11:08a prolonged period of time,
- 11:09even at some of the lower doses,
- 11:12because as I said,
- 11:14we have to start low and go high,
- 11:18and with the initial drug that targeted
- 11:21KRAS G12C, responses were seen
- 11:23regardless of what the dose was,
- 11:26which is extremely encouraging
- 11:27and that drug is moving forward
- 11:30hopefully to FDA approval.
- 11:33So I think that there's a few
- 11:35things there that you said that
- 11:38are so important to highlight,
- 11:40one of which is that our ability
- 11:42now to to figure out what the exact
- 11:45mutations are and to develop drugs
- 11:48that will target those mutations
- 11:50really not only benefits
- 11:52patients in terms of
- 11:55lack of side effects and potential
- 11:57better efficacy of a drug that
- 12:00targets a particular tumor,
- 12:01but it also really encourages
- 12:03patients to participate in
- 12:05clinical trials because you know
- 12:07that that drug, at least in animal models,
- 12:10has been shown to be efficacious
- 12:13against that particular mutation,
- 12:14and at least in animal models,
- 12:17doesn't have high toxicity.
- 12:18And so Pat,
- 12:20when you're designing a phase
- 12:22one trial and thinking about
- 12:24the patients who are eligible,
- 12:26I think the other thing that was really
- 12:29critical that you said was not only
- 12:32how you target the population to
- 12:35those patients who could
- 12:37potentially benefit from this,
- 12:38for example,
- 12:39those who have a specific mutation.
- 12:42But also those for whom
- 12:45standard of care may be falling
- 12:47short where there may not be other
- 12:50options who have been through
- 12:52a number of series of different
- 12:54regiments and have come to exhaust
- 12:57standard of care options tell us more
- 13:00about how you go about designing a
- 13:02phase one trial in terms of who's
- 13:05eligible and how
- 13:08many patients are eligible and how
- 13:10you kind of figure out how many patients
- 13:14you need to have on that trial
- 13:16to get the information that you
- 13:18need before you can open this up
- 13:21to wider clinical trials?
- 13:23Right, so first of all,
- 13:25there are a limited number of
- 13:27patients that go on the phase
- 13:30one trials because we're really
- 13:32looking for potential side effects
- 13:34of the drug to make sure that the
- 13:37drug is safe to give to patients.
- 13:40So we slowly increase the dose will
- 13:43treat one to three patients and we'll
- 13:45have to get them through at least
- 13:48three to six weeks of treatment
- 13:51before we then can increase the dose
- 13:54and add another one to three
- 13:56patients as an example.
- 14:00And so I wanted to pick up
- 14:02on all of the things that we
- 14:04look at in terms of Phase one,
- 14:07clinical trials and how we actually
- 14:09get these drugs to market right
- 14:11after we take a short break
- 14:13for a medical minute.
- 14:15Please stay tuned to
- 14:16learn more with my guest Doctor Pat LoRusso.
- 14:19Support for Yale Cancer Answers
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- 14:26Learn more at astrazeneca-us.com.
- 14:29This is a medical minute
- 14:31about smoking cessation.
- 14:32There are many obstacles to
- 14:34face when quitting smoking
- 14:36as smoking involves the potent drug nicotine.
- 14:39But it's a very important lifestyle change,
- 14:42especially for patients
- 14:43undergoing cancer treatment.
- 14:44Quitting smoking has been shown to
- 14:47positively impact response to treatments
- 14:49decrease the likelihood that patients
- 14:51will develop second malignancies
- 14:53and increase rates of survival.
- 14:55Tobacco treatment programs are
- 14:57currently being offered at federally
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- 15:01and operate on the principles
- 15:02of the US Public Health Service
- 15:05Clinical Practice guidelines.
- 15:07All treatment components are evidence
- 15:09based and therefore all patients are
- 15:11treated with FDA approved first line
- 15:13medications for smoking cessation as
- 15:16well as smoking cessation counseling
- 15:18that stresses appropriate coping skills.
- 15:20More information is available at
- 15:23yalecancercenter.org. You're listening
- 15:24to Connecticut Public Radio.
- 15:26Welcome
- 15:26back to Yale Cancer Answers.
- 15:28This is doctor Anees Chagpar
- 15:30and I'm joined tonight by
- 15:32my guest doctor Pat LoRusso.
- 15:34We're talking about
- 15:35experimental therapeutics,
- 15:36and phase one clinical trials,
- 15:38and right before the break,
- 15:40Pat, we were talking about how you
- 15:42go about designing these phase one
- 15:45first in man clinical trials and
- 15:47we were talking about the fact that,
- 15:49you know, it seems to me to be a little
- 15:53less scary than it was in previous years.
- 15:56Because drugs these days are so much
- 15:59more targeted and there is a lot of
- 16:02regulation and a lot of preclinical
- 16:04work in terms of animal studies,
- 16:07that goes into really making sure that
- 16:09these drugs are efficacious and not toxic,
- 16:12at least in a couple of animals
- 16:15species before it ever hits
- 16:17phase one clinical trials.
- 16:19But you were starting to tell us right
- 16:22before the break about how you design
- 16:25these phase one clinical trials.
- 16:27How many patients you involve,
- 16:29what your inclusion criteria are,
- 16:31the safeguards that you put
- 16:34around these trials.
- 16:35Because still, for some patients,
- 16:37this may seem really scary and
- 16:40often is used as a last resort,
- 16:43so can you
- 16:44talk a little bit about that?
- 16:48Oh yes,
- 16:49absolutely. And thank you for the
- 16:51opportunity to do so. So to begin with,
- 16:54how do we design these trials.
- 16:58In terms of finding the dose that we want to
- 17:01start with and how we're going to escalate,
- 17:05that pretty much comes from the toxicology
- 17:08studies that we've done before we get
- 17:10into the clinic before we go in demand.
- 17:13But also exposure of the drug.
- 17:15So what was the exposure that was needed
- 17:18in the various model systems that we
- 17:21used in order to see benefit to see
- 17:24the tumor regress either in the mouse
- 17:27models or in the in vitro Petri dishes?
- 17:30Because we know that we have to start safe.
- 17:34But we also want to make sure that
- 17:36we can get to an adequate exposure,
- 17:39because if we can't get
- 17:41to an adequate exposure,
- 17:43we are concerned that we may not see the
- 17:46benefit and oftentimes there is a very
- 17:48large what we call therapeutic window,
- 17:51a window or a dose at which we started to
- 17:55see activity to a dose where we saw side
- 17:58effects in animals and
- 18:01the easier it is for us to identify how
- 18:05fast we're going to increase our doses.
- 18:08Another thing is we look at the inclusion and
- 18:12exclusion criteria and in terms of toxicity,
- 18:15if we know that the drug preclinically in
- 18:18animals led to some type of a side effect,
- 18:22we have to select out our
- 18:24patients based on that,
- 18:26or do some additional tests to make sure
- 18:28we can hopefully safeguard patients and
- 18:32follow them closely so that
- 18:34they don't have a side effect.
- 18:37But in terms of efficacy as well,
- 18:39it would not be
- 18:42in 2021 because we know so much more
- 18:44about the science and how the science
- 18:47is driving the tumor in humans,
- 18:50we want to select out patients that will
- 18:52have the greatest chance of benefit.
- 18:55So back 25 years ago when I
- 18:57started doing Phase one trials,
- 18:59we would do what we called all comer studies.
- 19:03All patients, regardless of the tumor,
- 19:05were allowed to go on phase one trials.
- 19:08Because we didn't know enough about the
- 19:11science that was driving particular tumors.
- 19:14And nowadays in 2021 it's not
- 19:16uncommon for us to design a trial
- 19:19that may only have two tumors,
- 19:21or maybe two tumors and a third
- 19:24arm of tumors that have a specific
- 19:27mutation an like the KRAS G12C
- 19:30story that I was telling you about.
- 19:33We knew that the primary tumors that
- 19:36we needed to go after were the lung
- 19:39tumors that were either lung cancer
- 19:42or colon cancer that harbored
- 19:44this KRAS G12C mutation.
- 19:47But there are other tumors that
- 19:50rarely harbor this mutation as well.
- 19:52Cholangiocarcinoma,
- 19:53you know various tumors and so we
- 19:57allowed a third arm or a third
- 20:00basket of tumors to be enrolled
- 20:03of those different tumors that
- 20:05might have that mutation.
- 20:06Additionally,
- 20:07back in the olden days,
- 20:09we used to see patients that had failed
- 20:12everything, even drugs that really
- 20:14were not doing that much for them,
- 20:17but might have been FDA
- 20:19approved for commercial use.
- 20:21But nowadays we realize that
- 20:23that may not be the best patients
- 20:25to put on these studies,
- 20:28especially seeing that
- 20:29we're targeting science.
- 20:30And we're not looking necessarily for
- 20:32patients now that have exhausted everything.
- 20:35But like for instance,
- 20:36we have a trial that only wants
- 20:39patients that have failed what we call
- 20:42frontline therapy for colon cancer or
- 20:44frontline therapy for pancreas cancer.
- 20:46Only one treatment for their
- 20:48metastatic disease,
- 20:49and then we want to bring them on
- 20:52the trial because we know that
- 20:54the farther out you go in terms
- 20:57of number of different treatments
- 20:59that a patient is given,
- 21:02many times there's a significant
- 21:05decrease in the ability for that tumor
- 21:07to respond to a certain treatment,
- 21:10and so we're requesting even in early phase
- 21:14once we've gotten to that dose that
- 21:16we want to advance forward instead of
- 21:19just going right into a phase two,
- 21:23we may do what we call expansion cohorts.
- 21:26In that phase
- 21:27one trial and where we put only
- 21:30patients with colon cancer,
- 21:32or only patients with ovarian cancer.
- 21:35And only those that may harbor as an example,
- 21:38a certain mutation.
- 21:40Because we want to move the drug
- 21:43through as quickly as possible,
- 21:45but as safely as possible so that
- 21:48we can hopefully advance that drug
- 21:51right into a phase three trial,
- 21:54which is a randomized trial looking
- 21:56at standard of care versus the new
- 22:00drug or standard of care versus
- 22:02standard of care.
- 22:04Plus the new drug together so that
- 22:06we can hopefully advance that drug
- 22:09to commercialization to make it accessible
- 22:12to all patients that could benefit
- 22:15from that drug as quickly as possible.
- 22:18Yeah, I think that's so important right
- 22:21in thinking about the fact that even if
- 22:24you look at our standard chemotherapies,
- 22:27many of these are drugs that were
- 22:31developed back in the quote the good old days,
- 22:34which really aren't targeted and now
- 22:37that we have these targeted therapies
- 22:40it may be patients who
- 22:43have specific mutations.
- 22:44To really look at clinical trials before
- 22:48they've exhausted all of their options.
- 22:51So Pat, my next question is,
- 22:55do you find that patients are still
- 22:58resistant to looking at clinical trials?
- 23:01Do they have enough information
- 23:03about where to find these clinical
- 23:06trials and for the people who
- 23:09are listening on the radio today
- 23:11who may be thinking,
- 23:13I failed my first round of chemotherapy,
- 23:16or maybe even two rounds,
- 23:21and you know,
- 23:22how far do we keep going down the
- 23:24line thinking about the next line of
- 23:27therapy in the next line of therapy,
- 23:30all of which may be less effective
- 23:32versus trying a clinical trial.
- 23:34And how do I get information about
- 23:37what clinical trials are out there that
- 23:39might be well suited to me in my tumor?
- 23:45In the Connecticut area obviously you
- 23:47know Yale Cancer Center is an
- 23:50outstanding resource for clinical trials.
- 23:52And you know, contacting somebody
- 23:54at Yale Cancer Center,
- 23:56if you have a GI cancer
- 23:59cancer of the colon or stomach,
- 24:02contacting the GI team to see
- 24:05do they have trials available?
- 24:07Or if you have metastatic disease, your cancer
- 24:10is spread outside of its primary source,
- 24:13contacting our team as an example,
- 24:17and if you contact Yale,
- 24:21they will get ahold of the right physician
- 24:23to be able to answer those questions.
- 24:27You can also go on cancerclinicaltrials.gov,
- 24:29a website that is
- 24:32sometimes very difficult to maneuver.
- 24:35You can ask your primary oncologist,
- 24:37but depending on how comfortable
- 24:39they feel in referring you,
- 24:42you're at the disposal and
- 24:45you're at the mercy of them sending you
- 24:48for a second opinion or sending you to
- 24:52a site that may have clinical trials
- 24:55that may not be available to them.
- 25:00Sometimes it's very difficult for
- 25:03these patients to find these trials.
- 25:06Unfortunately,
- 25:07of all patients that are diagnosed
- 25:10and treated for cancer,
- 25:12less than 3% of them are ever
- 25:15put on a clinical trial,
- 25:18and there are certain communities
- 25:21of patients,
- 25:22the underrepresented minorities,
- 25:23those patients in rural communities
- 25:26that have the greatest
- 25:30impact of not being offered
- 25:33a clinical trial or not being able
- 25:36to get access to a clinical trial.
- 25:39So I mean,
- 25:40there are some organizations
- 25:42that you can contact
- 25:44that may help you find a trial
- 25:48or calling the NCI directly,
- 25:50but many times it's difficult
- 25:53unfortunately,
- 25:53to even maneuver those
- 25:55avenues of information.
- 25:58So Pat, you mentioned underrepresented
- 26:00minorities and I just want to pick up
- 26:04on this just for a minute because
- 26:06for many patients who may be
- 26:09from underrepresented minorities
- 26:10African American patients,
- 26:12for example, they may be reluctant
- 26:15to participate in clinical trials
- 26:18given historical events
- 26:20that have happened in this country,
- 26:23which have been deplorable in terms of
- 26:27clinical research and how it was conducted,
- 26:30can you alleviate some of their fears
- 26:34and anxieties?
- 26:37Because of some of those
- 26:40previous events that occur,ed
- 26:42especially with minority populations,
- 26:45the Food and Drug Administration
- 26:48the FDA has put very strict rules
- 26:51and regulations in place that
- 26:54will prevent that from happening.
- 26:57And in fact, there are many investigators,
- 27:01epidemiologists and scientists
- 27:02that are trying to understand
- 27:05why underrepresented minorities
- 27:07are not as well represented and the
- 27:10number one reason is because they
- 27:12are not offered a clinical trial.
- 27:15One of the other reasons is
- 27:18geographic and financial barriers.
- 27:20Those are two of the other reasons,
- 27:24but it isn't because they've
- 27:26necessarily refused a clinical trial,
- 27:29the lack of being offered
- 27:32far outweighs their refusal.
- 27:34The geographic barriers far
- 27:36outweigh their refusal,
- 27:38and in fact there are very,
- 27:41very slim statistics of the
- 27:43last 17 FDA approved
- 27:46cancer drugs and less than 4% of all
- 27:50patients that were recruited were black,
- 27:53less than 4% of all patients
- 27:57recruited were Hispanic,
- 27:59and those two underrepresented
- 28:01minorities represent a significantly
- 28:04larger population of cancer patients.
- 28:06And it's important to have
- 28:10underrepresented minorities offered
- 28:12and participate in clinical trials
- 28:15because we need to see if their tumors
- 28:19respond the same way their
- 28:21tumors may have some genetic,
- 28:23or some germline
- 28:25mutation or differences
- 28:27and we need to understand that
- 28:30and how it impacts their tumors.
- 28:35I think that's so important because
- 28:38at the end of the day,
- 28:40once all of these trials are done and these
- 28:44drugs are marketed as standard of care,
- 28:47these patients are going to receive
- 28:50these same therapies that may
- 28:52have been developed on a
- 28:54completely different population.
- 28:58So Pat very quickly in our last minute,
- 29:00I just want to get one last question in
- 29:03which is you mentioned financial barriers.
- 29:06Are clinical trials covered by
- 29:08insurance or do people have to pay
- 29:10out of pocket for these drugs?
- 29:13The drugs themselves,
- 29:14if they are investigational drugs,
- 29:18they do not have to pay for them.
- 29:21They will be given free
- 29:23of charge by the sponsors.
- 29:26Medicare coverage analysis
- 29:27covers a lot of the tests that
- 29:30are needed for clinical trials,
- 29:33but I think some of the greatest
- 29:36financial barriers are commuting
- 29:38back and forth to places
- 29:40some of the standard of care
- 29:43copays that are required,
- 29:45and hopefully we will be able
- 29:48to work towards getting a lot of
- 29:51those things funded through new
- 29:53initiatives that can help patients.
- 29:56Because the patients that need
- 29:58these studies the most sometime
- 30:00are patients that do have
- 30:03a problem gaining access to their
- 30:05copays or paying a babysitter so
- 30:07that they can go and
- 30:10participate in these clinical trials,
- 30:12or drive or pay for parking at the
- 30:15sites that they have to be treated.
- 30:20Doctor Pat LoRusso
- 30:20is a professor of medicine
- 30:23at the Yale School of Medicine.
- 30:25If you have questions,
- 30:27the address is canceranswers@yale.edu
- 30:29and past editions of the program
- 30:31are available in audio and written.
- 30:33Farm at yalecancercenter.org.
- 30:34We hope you'll join us next week to
- 30:37learn more about the fight against
- 30:39cancer here on Connecticut Public Radio.