The FDA approved avapritinib (Ayvakit) for the treatment of adults with advanced systemic mastocytosis (AdvSM), including those with mast cell leukemia (MCL), aggressive systemic mastocytosism (ASM), or systemic mastocytosis with an associated hematological neoplasm (SM-AHN), according to the agency.1

The approval marks the first targeted therapy that inhibits D816V mutant KIT, which is a main driver of AdvSM.

"Advanced systemic mastocytosis is a debilitating disease characterized by extensive damage in multiple organ systems due to mast cell infiltration, and new treatment options are urgently needed to address these life-threatening complications," said Daniel DeAngelo, MD, PhD, Chief of the Division of Leukemia at Dana-Farber Cancer Institute, in a statement.2 "Avapritinib will clearly establish a new standard of care for patients with advanced systemic mastocytosis. The FDA approval was based on data showing robust and durable responses, including complete remissions, and a favorable safety profile. For advanced SM patients, the approval of avapritinib shifts the treatment paradigm toward precision therapy that targets the primary driver of mastocytosis."

The approval was based on findings from the multi-center, open-label, single-arm EXPLORER and PATHFINDER clinical trials. The primary endpoint was overall response rate (ORR) per modified IWG-MRT-ECNM criteria, as adjudicated by a central committee. Other endpoints included duration of response (DOR), time to response, and changes in individual measures of mast-cell burden.

The trials included 53 patients who received daily avapritinib at doses up to 200 mg.

"As shown in two clinical trials, AYVAKIT provides remarkable clinical efficacy to patients with advanced systemic mastocytosis, and this approval solidifies the therapy's strong value proposition in this population. With a deep commitment to driving continued research innovation in collaboration with the mast cell disease community, we are now building on this progress with the goal of bringing the benefits of precision therapy to a broader range of patients through our ongoing and planned clinical trials for non-advanced systemic mastocytosis,” said Jeff Albers, CEO of Blueprint Medicines, the manufacturer or avapritinib, in a statement.

Between both trials, there was a 57% IRR (95% CI, 42,70), which included 28% complete remissions and 28% partial remissions. Average DOR Was 38.3 months (95% CI 19-not estimable), and the median time to patient response was 2.1 months.

Most common adverse events that occurred in 20% or more of patients were edema, diarrhea, nausea, and fatigue/asthenia.

"This milestone is also the culmination of many years of work across the systemic mastocytosis community, and we're proud of the contributions The Mast Cell Disease Society has made to improve the understanding of this disease, pioneer new approaches to measuring the impact of therapeutic interventions, and support the development of important medicines like AYVAKIT," said Lauren Denton, Executive Director of The Mast Cell Disease Society.

FDA. FDA approves avapritinib for advanced systemic mastocytosis. June 16, 2021. 

https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-avapritinib-advanced-systemic-mastocytosis?utm_medium=email&utm_source=govdelivery

Blueprint Medicine. FDA Approves Blueprint Medicines’ AYVAKIT (avapritinib) for the Treatment of Adults with Advanced Systemic Mastocytosis. June 16, 2021

Articles

The FDA approved avapritinib (Ayvakit) for the treatment of adults with advanced systemic mastocytosis (AdvSM), including those with mast cell leukemia (MCL), aggressive systemic mastocytosism (ASM), or systemic mastocytosis with an associated hematological neoplasm (SM-AHN). 

FDA Approves Avapritinib for Rare Blood Disease

In business, creative disruption (or innovative disruption) suggests that radical change in a marketplace is brought about by overturning existing conventions. Typically, some type of disturbance, expected or unexpected, occurs to alter the usual pattern of operating or doing business to create a new model.

In health care, a fitting example of this is reflected in how we have conversed with patients during the COVID-19 pandemic, which has migrated from calling to texting. Prior to the crisis, phone calls as the default mode of health care communication were already on the outs. Not surprisingly, only 18% of people say they listen to a voicemail from a number they don’t recognize.

 According to a recent survey of patients’ communication preferences before and during the pandemic, interest in phone calls had plummeted 14% in just a few months.

For providers and patients in a COVID-19 world, phone calls just weren’t getting the job done as well as they once had, for a variety of reasons. Seventy percent of people experienced longer call wait times than normal when trying to reach a business. Amid a health crisis, the last thing patients want is to be put on hold by their provider or interrupted by calls during the workday.

All told, things developed to a point where providers couldn’t effectively relay critical information about COVID-19, such as safety and protocols, park-and-wait instructions, and altered practice hours. Similarly, patients couldn’t quickly and easily get the information they needed when they needed it. Both parties were frustrated by the failure of phone calls to facilitate speedy interactions. As a result, it’s easy to see why patient satisfaction with health care communications during the pandemic fell by 7% compared with pre-pandemic figures, according to the communication preferences study.

Creative disruption took place when health care providers realized they already had the solution to their communication ills at their disposal—text messaging. For starters, texting offers a range of advantages over calling.

On average, it takes 4 seconds to send a text message, but a corresponding phone call can last a minimum of 2 minutes, and often much longer. Similarly, the response rate for texts is 209% higher than it is for phone calls, and most text messages are read within 15 minutes.

By automating scheduling tasks such as text appointment reminders and COVID-19 education messages, providers can connect clearly and effectively with patients while increasing confirmations and decreasing no-shows. Through the use of group texts, providers can message large numbers of patients with important COVID-19 information, details about vaccinations, and the latest health advisories with the click of a button.

Yet health care organizations aren’t the only ones to gain from the transition of patient-provider communications from calls to texts. Patients themselves are fully on board with texting as the new normal. Eighty-one percent of Americans own a smartphone, and 97% send a text at least weekly.

 Clearly, texting has become the preferred way to communicate because it’s quick and convenient, and people can respond to messages. in their own time. And when it comes to patients, text messaging is surging. Nearly 80% of patients in the survey said they wanted to receive text messages from their provider. Another 84% said they preferred automated communication as a faster and more efficient

It’s not just text messaging that is changing the way providers interact with patients. Real- time, 2-way messaging adds a whole new dimension to patient engagement. Through 2-way texting, providers can answer patients’ questions, follow up on no-shows, and conduct a conversation with patients while not over- whelming staff with time-consuming phone calls. According to the patient survey, 73% of patients want to be able to text their medical provider. That communications compatibility is a win-win for health care organizations and those they serve.

Ultimately, the disruption caused by the COVID-19 pandemic has made providers and patients reexamine how they interact and communicate. Texting has become the new way of calling, and its flexibility and efficiency are helping to build upon and improve the patient-provider relationship. Patients feel as though providers are listening better and being more responsive to their needs and preferences. The end result is a better health care experience for patients and improved levels of satisfaction with their provider.

Vanderkam L. Are you still checking voicemail? 

 April 11, 2013. Accessed April 19, 2021. 

https://www.cbsnews.com/news/are-you-still-checking-voice-mail/

Patient communication preferences: the COVID-19 impact. SR Health. Accessed April 19, 2021. 

https://www.srhealth.com/resources/the-covid-19-impact

Schwab N. New report: COVID-19 reveals the importance of texting during global crises. Zipwhip

https://www.zipwhip.com/blog/coronavirus-business-and-consumer-trends/

Burke K. Is texting really 10 times more efficient than phone calls? Test Request. September 29, 2015. Accessed April 19, 2021. 

https://www.textrequest.com/blog/texting-more-efficient-than-phone-calls 

Pew Research Center. April 7, 2021. Accessed April 19, 2021. 

https://www.pewresearch.org/internet/fact-sheet/mobile/#:~:text=mobile%20revolution%20below.-,Mobile%20phone%20ownership%20over%20time,smartphone%20ownership%20conducted%20in%202011

The last thing patients want is to be put on hold or interrupted by calls at work.

COVID-19 and the Rise of Texting in Health Care

While merkel cell carcinoma (MCC) tends to have poor prognoses and limited treatment options, promising response rates with checkpoint inhibitors may pave the way for better treatment for the rare skin cancer, according to James A. DeCaprio, MD. 

“Within the medical community there has been awareness raised for MCC because of the success [seen] with checkpoint blockade therapy,” said DeCaprio. “Now, more people know about MCC, and even people who are not involved in skin cancer [treatment] are aware of it. We’re never going to see an ad on TV for MCC treatment because it is rare, but there are certainly opportunities to build on the really spectacular responses to checkpoint blockade [we’ve seen].”

For example, the novel, oral, MDM2 small molecule inhibitor KRT-232 is being evaluated in a phase 2 study (NCT03787602) for patients with 

 wild-type MCC who have failed treatment with a PD-1/PD-L1 inhibitor.

 Initial results of the study demonstrated early efficacy signals and good tolerability with KRT-232 monotherapy in this patient population.

, DeCaprio, a physician at Dana-Farber Cancer Institute and a professor of medicine at Harvard Medical School, discussed the incidence of MCC, risk factors for the disease, established treatment options, and investigational regimens on the horizon.

: MCC is a very interesting cancer. It is among the rarer skin cancers; it is 40 times less common compared with melanoma and many times less common compared with squamous cell carcinoma and basal cell carcinoma. MCC is highly aggressive, so we can’t fool around with [diagnosing] it. It shows up as an innocuous little skin bump but can grow very quickly. Usually, just the speed of growth has a patient coming to their doctor.

Many patients with MCC already have a dermatologist because they have a history of skin cancer, such as squamous cell carcinoma or basal cell carcinoma. A few patients with melanoma have also gone on to develop MCC.

[The incidence of MCC] is about 1 per 100,000 in the United States. The incidence is going up, however. Part of that increase in incidence is because MCC is a rare cancer. It was only first described in 1972 by [the late] Cyril Toker, [MBBCh, FRCS, MS, JD, of the University of Maryland]. MCC is rarely suspected when a patient shows up with a skin bump. Most pathology specimens do not have [the ability to] rule out MCC on the clinical diagnosis. In fact, I’ve only seen one pathology report even suggest that [a patient] could have MCC. Usually, MCC is thought to be a benign cyst that [can be resected]. Then, the pathologist will call back and let [the patient] know it is MCC.

Sunlight exposure, as well as age, are contributing to the rising incidence of MCC. MCC can show up in younger people in their 20s with tanning bed exposure, as well as in people in their 30s and 40s. The incidence starts taking off in [individuals between the ages of] 60 years to 90 years.

What are some of the risk factors for MCC?

One risk factor for MCC is sunlight exposure or intense ultraviolet (UV) exposure. Often sun-exposed areas, such as the face, neck, arms, and legs, are where many MCC [nodules] show up.

Maybe as much as 10% of all patients with MCC are immunocompromised in some way. Solid organ transplantation is another risk factor, as well as the treatments of some autoimmune diseases, such as rheumatoid arthritis, and psoriatic arthritis. Therefore, there is an immune component to this disease, both in its risk factors and treatment. We have had a few patients have some genetic predisposition to immunosuppression as well.

MCC is rare even under all of those circumstances. Most people with psoriatic arthritis do not develop MCC, but it is definitely a risk factor.

How do you categorize some of the unique challenges in MCC?

There are 2 unique challenges with MCC: one is on the biologic side and the other is on the clinical side.

On the biologic side, MCC can be caused by excessive UV damage to the tumor genome [that causes] lots of mutations. The other form of MCC is caused by the Merkel cell polyomavirus. This virus is very common; everyone has it living on the skin. On the wrong day, the virus can get into the wrong place and become integrated into a normal cell to transform it into MCC.

The tumors of [both forms] of MCC look and act identically. They are almost indistinguishable in where they show up on a patient, who is at risk, and how they respond to treatment; it’s quite striking. The similar phenotypes, presentations, histologies, and biologies, but completely unique etiologies are why I study MCC. How does this [polyomavirus] trick a normal cell into becoming this highly aggressive cancer? [The UV-exposure form] helps us to decipher thousands, if not millions, of mutations that UV light [can] introduce into the tumor genome. What driver mutations are really causing the cancer?

On the clinical side, MCC is a solid tumor with the highest response rate to checkpoint inhibitor therapy. PD-1/PD-L1 antibodies have dramatic activity in [patients with] MCC [inducing response rates of] 50% to 60%, often for quite a long time.

It’s great news that MCC responds, but why does it do that? Conversely, why do some patients with MCC not respond to checkpoint blockade? There are a lot of very important questions [being asked] related to that. Of course, we use the biology of this virus to understand this phenotype as well as why [a patient’s disease] would be sensitive [to checkpoint inhibitors] or not.

The other unique thing about MCC is that it shows up commonly on the head and neck area [where] a lot of important and complicated structures [are], but it can also show up in the hands. Because MCC is a rare cancer, there is not much experience in treatment. However, it is very clear that we need skilled teams of physicians that can take care of these patients. These tumors are very sensitive to radiation therapy; radiation can cure MCC without the need for disfiguring surgery to remove the entire tumor. How much of the tumor do we need to remove? How much do we need to radiate? Is there need for additional therapy, such as checkpoint blockade? Often, a lot of morbidity related to surgery or chemotherapy could be spared if the team has experience and knows how to best take care of these patients [with a good] treatment plan.

How have checkpoint inhibitors improved upon historical treatment, such as chemotherapy? How can the field improve upon responses with checkpoint inhibitors?

The world is completely different since 2016 with the first report of checkpoint blockade response in MCC. Up until 2016, we were commonly giving chemotherapy with cisplatin or carboplatin plus etoposide for advanced cases of MCC. This is very toxic chemotherapy but very effective in MCC. Most patients would respond rapidly to that form of therapy.

Chemotherapy itself is immunosuppressive so we were inhibiting the body’s own immune system in trying to protect against MCC by using a cytotoxic therapy. It was also recognized that the responses to chemotherapy did not last that long—maybe 2 to 3 months on average.

When checkpoint inhibitors became available and showed efficacy in MCC, it changed practice dramatically. Pembrolizumab [Keytruda] and avelumab [Bavencio] were both FDA approved rapidly with very small case numbers because responses were so dramatic and there wasn’t an FDA-approved alternative. [The treatment landscape] is completely different now since 2016.

In melanoma, we know that checkpoint inhibitors are also very effective, but [they don’t elicit] response rates as high as 50%. Often in melanoma, the response duration is quite long, [meaning] up to several years. I think of [former president] Jimmy Carter [who has melanoma with brain metastases] and how well he has responded to checkpoint inhibitors for years now.

In MCC, the responses to checkpoint inhibitors may not last as long [as they do in melanoma], so physicians are forced to adapt their checkpoint blockade by changing the dosing schedule, drug, or combining drugs. Because the response durations are not as long, there are significant challenges and opportunities to improve what is already a success story.

Can we extend the responses for patients who do respond? Can we improve the response? Can we find something to help patients who don’t respond at all, either up front or later on? A lot of key challenges [exist].

We study the biology of the virus, which has definitely given us clues about how to go after virus-positive MCC. One of the opportunities [to improve upon responses] is [to use] p53 and MDM2 inhibitors. As it turns out, the polyomavirus goes after 

 susceptible to MDM2 inhibition; it is a unique virus in that sense. It gives us the perfect opportunity to activate 

 by inhibiting MDM2. Papillomavirus, for example, goes after 

 very well, but it eliminates our opportunity to activate it. We haven’t been able to get in the middle of papillomavirus and 

. In MCC, polyomavirus leaves itself exposed to 

 activation. There is a phase 2 clinical trial [NCT03787602] from Kartos using KRT-232, a small molecule inhibitor for MDM2, that is showing very promising activity. We are excited about that and hopefully we will hear more about it in the coming months.

Are there other research efforts ongoing that you would like to highlight?

There is a great [clinical] opportunity with MDM2 [inhibitors] but related to that are MDM4 [inhibitors]. 

 work collaboratively with each other to get rid of 

. Our lab has found that we can independently inhibit MDM2 and MDM4, and that combination will synergistically activate 

. There is a golden opportunity to target 

 together, so with some luck, we will have an [FDA] approval for MDM2 inhibitors [, and potentially MDM4 inhibitors, in the future]. This can also be expanded for drugs that inhibit both [MDM2 and MDM4].

Another pathway we’ve uncovered is LSD1. There is an opportunity for LSD1 inhibitors in MCC and we have talked to a few companies [about trials to that end]. Because MCC is rare, it makes it challenging to put together a study. The MCC that we have studied has been very sensitive to LSD1 inhibitors.

Because the virus is driving a normal cell [to turn into a cancer cell], we’ve found several other targets that could be opportunities for therapy. We are just getting started and there is certainly a really interesting possibility that one of the drug targets could synergize with checkpoint inhibitors. We could have a rational strategy to inhibit checkpoint blockade but then work with the virus to activate the immune response. We will look at some inhibitors in that regard too. Hopefully, we will all be reading about that soon.

How can the community raise awareness for MCC?

In Australia, MCC is a household word and is well understood because of [Australians’] increased risk for all skin cancers. MCC is of a higher incidence [in Australia]—though it is still rare—so it is well understood.

Although melanoma, for example, is a terrible disease, patients can often live a long time with it, particularly when it is caught early before metastasizing. Now, because of certain therapies, even patients with metastatic disease live long to tell their story. MCC is so aggressive that patients don’t often live to tell their story. Patients with stage I or II disease with just a lump and no lymph node [involvement] can mostly be cured.

[Advanced-stage disease] is highly aggressive. Those are the patients we are trying to learn from so that some of them will be able to tell their stories. We are getting some success in this disease. Encouraging patients to tell their stories is one way to get the word out.

This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with (p53WT) Merkel cell carcinoma who have failed anti-PD-1/PD-L1 immunotherapy. ClinicalTrials.gov. Updated December 20, 2019. Accessed June 1, 2021. https://clinicaltrials.gov/ct2/show/NCT03787602.

Wong MKK, Kelly CM, Burgess MA, et al. KRT-232, a first-in-class, murine double minute 2 inhibitor (MDM2i), for TP53 wild-type (p53WT) Merkel cell carcinoma (MCC) after anti–PD-1/L1 immunotherapy. 

. 2020;38(suppl 15):10072. doi:10.1200/JCO.2020.38.15_suppl.10072


This article was originally published on OncLive as, "

Novel Targets Set to Add to Checkpoint Blockade Success in Merkel Cell Carcinoma

While merkel cell carcinoma (MCC) tends to have poor prognoses and limited treatment options, promising response rates with checkpoint inhibitors may pave the way for better treatment for the rare skin cancer. 

New Targets May Improve the Treatment of Rare Skin Cancer

In an age of information overload, it can be difficult for patients with cancer
to comprehend their diagnosis and navigate the associated health care
decisions. Even within the health care field, misconceptions and uncertainty
about the role of clinical trials often abound. It is imperative that nurses and
health care providers feel comfortable discussing with patients the part trials
play. Clinical trials are the vital bridge between research and a drug’s eventual availability to patients. The process comes to a halt if there is not enough
accrual for the study to take off, and poor enrollment is the predominant reason that clinical trials fail.

 Nurses can not only help to educate but also spread the word among their peers and patients. The more expeditiously trials can accrue, the faster drugs can get through the process and into the hands of clinics and patients.

Many barriers to clinical trial enrollment exist, including logistical concerns, assumed lack of access, and therapeutic concerns. Investigators in a number of studies evaluating these barriers have noted a lack of education regarding trials to be the most common barrier.

 When nurses have a firm grasp on the basics of clinical trials, including the different phases and how to explain them to patients, the conversation will be normalized. The more secure nurses are with this discussion, the more comfortable their patients will feel about bringing up the topic and keeping an open mind. For instance, it has long been a misconception that clinical trials are reserved for the time when standard- of-care options have failed. In fact, the National Comprehensive Cancer Network recommends clinical trials as the best option for any patient who receives a cancer diagnosis.

To give a snapshot, the FDA approved 92 novel cancer drugs for 100 indications based on data from 127 clinical trials.

These are therapies that went through the rigorous process to approval and are now additional treatment options for patients who may currently be receiving treatment in your clinic. But for patients, reinforcing that safety is clinical trials’ primary focus is paramount, and engrained by strict training requirements, detailed reporting systems, and strict protocols for which adherence is non-negotiable.

Many resources are available for additional information on clinical trial options. These include the physicians or advanced practice providers at your practice, oncology-focused conferences, and the clinicaltrials.gov website, to name a few. Empowering our colleagues to stay well informed and feel comfortable talking to patients about clinical trials can have a long-lasting impact on trial enrollment and advancement and, most importantly, on patients’ comfort and understanding. It is time to normalize the conversation for science, the continued growth of nurses, and the overall survival of our patients.

Unger, J. M., Cook, E., Tai, E., & Bleyer, A. (2016). The Role of Clinical Trial Participation in Cancer Research: Barriers, Evidence, and Strategies. 

American Society of Clinical Oncology educational book. American Society of Clinical Oncology. Annual Meeting

Ford, J.G., Howerton, M.W., Lai, G.Y., Gary, T.L., Bolen, S., Gibbons, M.C., Tilburt, J., Baffi, C., Tanpitukpongse, T.P., Wilson, R.F., Powe, N.R. and Bass, E.B. (2008), Barriers to recruiting underrepresented populations to cancer clinical trials: A systematic review. Cancer, 112: 228-242. 

National Comprehensive Cancer Network. NCCN Guidelines Version 2.2021-Pancreatic Adenocarcinoma.https://www.nccn.org/professionals/physician_gls/pdf/pancreatic.pdf. May 10, 2021.

Ladanie A, Schmitt AM, Speich B, et al. Clinical Trial Evidence Supporting US Food and Drug Administration Approval of Novel Cancer Therapies Between 2000 and 2016. 

"Clinical trials are the vital bridge between research and a drug’s eventual availability to patients.The process comes to a halt if there is not enough accrual for the study to take off. This is where nurses can not only help to educate but also spread the word among their peers and patients."
—Megan Price, MSN, APRN, FNP-C

Normalize the Clinical Trial Conversation


After hearing about the difficulties a transgender man faced in receiving a cancer diagnosis, Kelly S. Haviland, PhD, FNP-BC, found her calling. In this episode, Haviland, nurse research scientist and family nurse practitioner at Memorial Sloan Kettering Cancer Center, discusses how LGBTQ treatment has changed over the years, though there is still much more work to be done.

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Discrepancies Exist Between Actual Care and Trial-Based Recommendations in MCL

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KRAS mutational status and geographical region were associated with time on treatment (TOT), and body mass index (BMI) and age were linked with overall survival (OS) in patients with metastatic colorectal cancer mCRC) being treated with second-line cetuximab (Erbitux) after irinotecan or oxaliplatin-based regimens.

Patient Characteristics Linked to Time on Treatment and Survival in Patients With mCRC Receiving Cetuximab

While cabozantinib exposure was not a predictor of progression-free survival, it was related to high rate of palmar-plantar plantar erythrodysesthesia  and diarrhea in patients with advanced renal cell carcinoma who are given frontline cabozantinib plus nivolumab. 

Cabozantinib Associated With Higher Rates of Certain AEs in Advanced Kidney Cancer

The FDA approved injectable technetium Tc 99m tilmanocept (Lymphoseek), a radiopharmaceutical agent that targets lymphatic mapping and guiding for sentinel lymph node biopsies (SLNB), for use in pediatric patients with melanoma, rhabdomyosarcoma, and other solid tumors.

FDA Approves Radiopharmaceutical Diagnostic Agent for Pediatric Patients

This year, there were many takeaways from the American Society of Clinical Oncology Annual Meeting that oncology nurses can incorporate into their practice.

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Getting an accurate history – and doing so in a comfortable and non-judgmental way – can improve cancer care for LGBTQ patients. 

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Men with asymptomatic or mildly symptomatic metastatic castration-resistant prostate cancer who are being treated with radium-223 (Xofigo) plus enzalutamide (Xtandi) can reduce their risk of fractures with the use of bone-protecting agents.

Bone-Protecting Agents Reduce Fracture Risk During Prostate Cancer Treatment

The second-generation 4-1BB bi-specific CAR T-cell therapy was efficacious and safe in treating patients with relapsed/refractory B-cell non-Hodgkin lymphoma.

Second-Generation CAR T-Cell Therapy Is ‘Highly Promising’ in Relapsed/Refractory B-NHL

Sacituzumab govitecan, an antibody drug conjugate, maintained survival and response benefits over chemotherapy regimens.

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Survival rates were similar between the 2 drugs, but acalabrutinib had fewer adverse events.

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