The Food and Drug Administration (FDA) granted an accelerated approval to pembrolizumab (Keytruda) plus trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the frontline treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma.

The approval was based on interim findings from the ongoing multicenter, randomized, double-blind, placebo-controlled KEYNOTE-811 trial. The trial included 264 patients with HER2-positive advanced gastric or GEJ adenocarcinoma who had not previously received systemic therapy for metastatic disease. Half the patients received 200 mg of pembrolizumab every 3 weeks in combination with trastuzumab and either fluorouracil plus cisplatin or capecitabine plus oxaliplatin.

The overall response rate, as assessed by a blinded independent review committee, was 74% in the pembrolizumab arm, and 52% in the placebo arm. Average duration of response was 10.6 months (range 1.1 months to 16.5 months) for the immunotherapy agent, compared with 9.5 months (range, 1.4 months to 15.4 months) for the placebo arm.

Researchers said that the adverse event profile observed in KEYNOTE-811 is consistent with the known safety profile of the drug.

The recommended dosing for this patient population is 200 mg of pembrolizumab every 3 weeks or 400 mg every 6 weeks.

FDA. FDA grants accelerated approval to pembrolizumab for HER2-postive gastric cancer. May 5, 2021. 

https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-pembrolizumab-her2-positive-gastric-cancer?utm_medium=email&utm_source=govdelivery

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The FDA granted an accelerated approval to pembrolizumab plus trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the frontline treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma. 

FDA Approves Frontline Pembrolizumab for HER2+ Gastric, GEJ Cancer

The EGFR TKI osimertinib (Tagrisso) has shaken up the treatment paradigm of advanced non–small cell lung cancer (NSCLC), and now the agent is under exploration in earlier-stage settings in an effort to further prevent recurrence and prolong survival, according to Edward S. Kim, MD, who added that the key to reaching patients earlier is to test for biomarkers earlier.

“In the early-stage setting, it is devastating when [patients experience] recurrence. Hopefully, [with osimertinib,] we can do something about it and treat them. Too many times, because of the nihilism that has built up over the years, we are just waiting for the recurrence to occur,” Kim said. “I hope we get to a point where recurrence is less common, and we are treating more patients with earlier-stage disease. Our paradigm has changed. We will continue to study other drugs and targets in these settings, as well.”

 during an Institutional Perspectives in Cancer webinar on lung cancer, Kim, physician-in-chief of City of Hope Orange County and vice physician-in-chief of City of Hope National Medical Center, highlighted the impact of osimertinib in the treatment of patients with 

-mutant NSCLC, next steps with the agent, and the importance of early genetic testing to provide personalized care.

: How has the emergence of osimertinib impacted the management of patients with

 has really been one of the pioneering biomarker pathways in lung cancer. Osimertinib is the preferred drug because it has very strong efficacy and a [favorable] safety profile. The newer-generation drugs penetrate the brain and the central nervous system much more predictably than older-generation agents; this has changed the paradigm of how we approach patients who have initially been diagnosed with brain metastases. If they are stable, then we do not jump right to radiation. Instead, we treat them [with these drugs] if they have a mutation and watch them in case we need the radiation. [However,] it is great to see even our radiation colleagues embrace these data.

What are some areas of focus in the realm of

Throughout our investigations, we have also found other mutations in 

; some are sensitizing, some are resistant, and some we are not sure about yet. We are developing drugs [to target] these specific mutations, which is exciting. That is what we dream [to do with] cancer [treatment]: identify a marker in the tumor that is unique to an individual and finding a [targeted] therapy that [that is efficacious and] will not cause many adverse effects [AEs].

 moving into the earlier-stage setting; this [development,] indeed, follows what we have seen in the breast cancer paradigm. You have drugs that [are initially used in the] metastatic [setting], like tamoxifen, that are now moving into the earlier-stage setting. [Patients] can take [these agents] for several years and [they are effective]. We are seeing that now with osimertinib, [which is under examination] in the early-stage setting, in patients who have stage IB through IIIA [disease].

 mutations. If you find one, then after you finish the surgery and/or give chemotherapy, [you can] then treat the patient with osimertinib for 3 years; this has been shown to greatly improve disease-free survival [DFS]. We are still waiting for overall survival [OS] data [with this approach]. However, the trial [that examined this strategy] was unblinded early because of its effectiveness, and patients are still being treated.

[Treatment has] really cascaded in the direction [where] we want to reach patients earlier—especially those who have curable disease or curative intent disease. [We want to] try to keep disease away as long as possible. I am really happy that biomarkers have made it into the clinic. I urge everyone out there to test [for] biomarkers. Ensure that you are testing for these before you initiate any treatment. It does not matter if you are using smaller panels or larger panels; just ensure that you are getting that information and utilizing it to inform decisions.

Looking more closely at the use of osimertinib in the adjuvant setting, how did the agent perform in the phase 3 ADAURA trial (NCT02511106)? What does this information mean for practice?

The primary end point of ADAURA was DFS, specifically in [patients with] stage II and IIIA [disease], although the trial did enroll [those with] IB through IIIA [disease]. DFS was the first reported outcome because you get those outcomes earlier. Data were revealed early because of the effectiveness [of the agent]; this [runs] parallel to what happened with tamoxifen.

The hazard ratios for DFS were unprecedented. We had not seen that magnitude [of benefit] in lung cancer [previously], although we should; this is a curative intent population. We are asking patients to take a drug for up to 3 years and need to show that there is some benefit. Some would say we need to wait for OS and, of course, our due diligence has to be to wait for [those data].

However, you have to ask yourself, if this was a friend or family member, and they had gone through lung cancer resection, would you prescribe them osimertinib if they have an 

 mutation? My answer is a very clear yes. I do believe that DFS is an important end point, and it is one that we use quite often in earlier stages [of disease]. If you consider any patient who has had early-stage breast cancer and they get a recurrence, it is just devastating.

How are the AEs associated with osimertinib being managed? Are there any challenges to using this agent in the clinic?

What has been really helpful is that osimertinib was first approved [for use] in the advanced metastatic setting. Clinicians gathered quite a bit of experience with not only this drug, but also with drugs that were similar in class. We all remember using gefitinib [Iressa], erlotinib [Tarceva], afatinib [Gilotrif], and now, we have osimertinib. There is a comfort level [with these agents]. Again, the parallels [to what has been seen in the] breast cancer [paradigm] are there. Tamoxifen was first used in the metastatic setting and [people felt comfortable] dealing with those AEs.

On the whole, osimertinib has a very [safe] toxicity profile, when considering other classes of drugs [that are used] in the metastatic setting. Upon conducting the study and reporting out, we really did not see any new safety [signals]. As we consider primary end points and focus on the [patients with] stage II and IIIA disease, even in the total analysis of [those with] IB through IIIA [disease], we saw a benefit across the board. [Osimertinib] is [an agent] that people are comfortable with and we [have] quite a bit of experience [with its use].

This article was originally published on OncLive as, "

Research Efforts Focus on Reducing Recurrence in Early-Stage EGFR-Mutant NSCLC

Edward S. Kim, MD, highlights the impact of osimertinib in the treatment of patients with EGFR-mutant non–small cell lung cancer, next steps with the agent, and the importance of early genetic testing to provide personalized care.

Reduce Recurrence in Early-Stage NSCLC

Ethical dilemmas are unavoidable when caring for patients with cancer, and oncology nurses are often tasked with resolving such issues, relying on professional codes and standards to help guide what is best for the patient.

“One thing about ethical issues is that there’s usually not a right or a wrong. We’ve always tried to go for the best solution for the patient and the family, as well as the care team in the situation,” said Joyce Neumann, PhD, APRN, AOCN, BMTCN, FAAN, an advanced practiced registered nurse and adjuvant ethicist at The University of Texas MD Anderson Cancer Center. Neumann recently led a presentation on ethical dilemmas in oncology nursing at the 46th Annual ONS Congress.

While end-of-life care can highlight ethical dilemmas, the challenges actually start at diagnosis, when nurses are faced with educating patients and their family members, determining goals of care, discussing clinical trial participation, and assessing patients physically, cognitively, and psychologically.

Then comes the informed consent process, preparing for possible outcomes of treatment, establishing advanced care planning and goals of care – both through treatment and potentially at the end of life.

For example, nurses may need to balance being positive and providing hope with providing realistic information and expectations to patients and their loved ones.

Neumann explained that there were 669 ethics consults at MD Anderson between September 2015 and August 2020; 29% were filed by nurses. The most common reasons for these requests were inquiring about the appropriate levels of treatment.

“Probably the most major ethical challenge that we come to is when is enough enough, and when do we transition patients from curative or aggressive care to comfort care?” Neumann said.

One major way to address these ethical dilemmas in cancer care is to promote advanced care planning – where patients’ wishes, delegation of medical decision maker, and more are clearly documented for the patient, family, and clinical staff members.

Nurses should also consider patients’ comorbidities, prognosis, religious or spiritual views, and goals to help guide the best possible care.

“We obviously need to know patient preference – I can’t stress that enough,” Neumann said. “Does the patient have capacity for their decisions and those type of questions on quality of life? What does that mean to the patient? … If the patient does not have the capacity, can the family explain to us what conversations they’ve had with the patient prior to treatment starting, [regarding] views of care?”

Knowing your patient’s beliefs and goals is key to providing ethical cancer care.

Expert Talks Ethics in Oncology Nursing

The rolling submission of a new drug application (NDA) to the FDA for surufatinib for the treatment of patients with pancreatic and non-pancreatic neuroendocrine tumors (NETs) has been completed, according to an announcement from Hutchinson China MediTech Limited.

The application is supported by findings yielded from 2 phase 3 trials of the agent that were conducted in patients with NETs in China: SANET-p (NCT02589821) and SANET-ep (NCT02588170). The application also includes data from a study that was done in patients with pancreatic and non-pancreatic NETs in the United States.

Previously, the company had reached an agreement with the regulatory agency during a pre-NDA meeting that these studies could serve as the basis to support an NDA submission. The data package will also be used to submit a marketing authorization application with the European Medicines Agency this year. The company also shared that it would initiate an Expanded Access Protocol to ensure that surufatinib is accessible to patients who have limited therapies available to them.

“HUTCHMED is developing 6 novel oncology drug candidates internationally and this surufatinib NDA represents our first ever in the United States,” Marek Kania, MD, MBA, managing director and chief medical officer of HUTCHMED International Corporation, stated in a press release. “Having successfully launched surufatinib in China early this year, we are now looking forward, subject to its approval, to being able to provide access to this important new therapeutic option for [patients with] NETs in the United States and beyond.”

In SANET-p, about 195 Chinese patients who had low- or intermediate-grade advanced pancreatic NETs for whom no effective therapy was available underwent a 2:1 randomization to receive either oral surufatinib at a daily dose of 300 mg or placebo on a 28-day treatment cycle.

Patients had to have well-differentiated pancreatic NETs that was grade 1 or 2, locally advanced disease or have distant metastasis, documented radiologic progression within 1 year, and progression on 2 or less previous systemic treatments for advanced disease. They could not have progressed on VEGF or VEGFR inhibitor, nor could they have functional NETs that needed treatment with long-acting somatostatin analogues.

The primary objective of the trial was investigator-assessed progression-free survival, while key secondary end points comprised objective response rate (ORR), disease control rate (DCR), time to response (TTR), duration of response (DOR), and overall survival (OS), as well as safety and tolerability.

A total of 172 patients were randomized; 113 patients received surufatinib, while 59 were given placebo. The median investigator-assessed PFS in the surufatinib arm was 10.9 months (95% CI, 7.5-13.8) vs just 3.7 months (95% CI, 2.8-5.6) in the placebo arm (HR, 0.491; 95% CI, 0.319-0.755; 

 = .0011), meeting the superiority criteria of PFS for the trial. Moreover, PFS benefit was found to favor surufatinib across major patient subgroups evaluated.

The blinded independent image review committee (BIIRC)–assessed PFS proved to be consistent with the investigator-assessed PFS, at 13.9 months (95% CI, 11.0-24.9) in the investigative arm vs 4.6 months (95% CI, 3.6-7.4) in the control arm (HR, 0.339; 95% CI, 0.209-0.549; 

Moreover, surufatinib elicited an ORR of 19.2% (95% CI, 12.2%-28.1%) vs 1.9% (95% CI, 0.0%-10.1%) with placebo (

 = .0021). The DCR was 80.8 months vs 66.0 months with surufatinib vs placebo, respectively (

 = .0774), while the TTR was 3.8 months and 7.4 months, respectively. Moreover, the DOR with surufatinib was 7.4 months. At the time of the data presentation at the 2020 ESMO Virtual Congress, OS data remained immature.

The safety profile of the agent was noted to be manageable and consistent with data from previous studies.

In the randomized, double-blind, placebo-controlled SANET-ep trial, 198 patients with unresectable or metastatic, well differentiated, extrapancreatic NETs were enrolled.3 Patients had to be at least 18 years of age, have an ECOG performance status of 0 or 1, and could not have progressed on more than 2 types of prior systemic therapies.

Patients were randomized 2:1 to receive oral surufatinib at a daily dose of 300 mg (n = 129) or matching placebo (n = 69). Stratification was based on tumor origin, pathological grade, and prior treatment received. The median follow-up for the investigative and control arms was 13.8 months and 16.6 months, respectively.

Results showed that the median investigator-assessed PFS with surufatinib was 9.2 months (95% CI, 7.4-11.1) vs 3.8 months (95% CI, 3.7-5.7) with placebo (HR, 0.33; 95% CI, 0.22-0.50; 

 <.0001). The median PFS per BIIRC was 7.4 months (95% CI, 5.6-9.3) with surufatinib vs 3.9 months (95% CI, 3.7-5.8) with placebo (HR, 0.66; 95% CI, 0.44-0.98; 

Additionally, surufatinib elicited an investigator-assessed ORR of 10.0% (95% CI, 5.6%-17.0%) in the interim intent-to-treat population. The DCRs were 87.0% vs 66.0% in the investigative and control arms, respectively. Moreover, the TTR was 3.7 months with surufatinib, and the DOR was 5.6 months.

Regarding safety, again, the agent demonstrated an acceptable toxicity profile. The most frequently experienced treatment-related adverse effects (TRAEs) that were grade 3 or higher were hypertension (36.0% vs 13.0% with surufatinib and placebo, respectively), proteinuria (19.0% vs 0.0%), and anemia (5.0% vs 3.0%).

A multicenter, single-arm, open-label phase 1b/2 trial also examined surufatinib in patients with histologically well-differentiated, low- or intermediate-grade, inoperable or metastatic NETs. Here, patients were stratified by subtype: pancreatic (n = 41) or non-pancreatic (n = 39).

Data indicated that the agent elicited an ORR of 19.0% (95% CI, 9.0%-34.0%) in those with pancreatic NETs and 15.0% (95% CI, 6.0%-31.0%) in those with non-pancreatic NETs. Moreover, the median PFS was 21.2 months and 13.4 months in the investigative and control arms, respectively. The most frequently reported grade 3 or higher TRAEs with surufatinib were hypertension (33.0%), proteinuria (12.0%), hyperuricemia (10.0%), hypertriglyceridemia (6.0%), diarrhea (6.0%), and alanine aminotransferase increase (5.0%).

HUTCHMED completes rolling submission of NDA to US FDA for surufatinib for the treatment of advanced neuroendocrine tumors. News release. Hutchinson China MediTech Limited. May 3, 2021. Accessed May 3, 2021. https://bit.ly/3nLmMMM

Xu J, Shen L, Bai C, et al. Surufatinib (s) for patients (pts) with advanced pancreatic neuroendocrine tumours (SANET-p): a randomized, double-blind, placebo (p)-controlled phase III trial (NCT02589821). 

. 2020;31(suppl 4):S770. doi:10.1016/j.annonc.2020.08.1369

Xu J, Shen L, Zhou Z, et al. Surufatinib in advanced extrapancreatic neuroendocrine tumours (SANET-ep): a randomised, double-blind, placebo-controlled, phase 3 study. 

. 2020;21(11):1500-1512. doi:10.1016/S1470-2045(20)30496-4

Xu J, Li J, Bai C, et al. Surufatinib in advanced well-differentiated neuroendocrine tumors: a multicenter, single-arm, open-label, phase Ib/II trial. 

. 2019;25(12):3486-3494. doi:10.1158/1078-0432.CCR-18-2994

Rolling Submission Completed for Surufatinib in Advanced Neuroendocrine Tumors.

The rolling submission of a new drug application to the FDA for surufatinib for the treatment of patients with pancreatic and non-pancreatic neuroendocrine tumors has been completed.

Rolling Submission Completed for Surufatinib to Treat Advanced NETs

Oncology nurse practitioners are a crucial population in the healthcare arena. In an attempt to usher more nurses into the oncology NP career path, City of Hope teamed up with Azusa Pacific University School of Nursing to create the Oncology Nurse Practitioner Fellowship.

The results of the program were evaluated in a presentation at the 46th Annual Oncology Nursing Society Annual Congress.

“The role of the oncology [advanced practice provider] requires extensive training and education in a specialized area practice,” said Katherine Butcher, NP, MSN, a nurse practitioner at City of Hope who recently completed the program.

Of note, many states have given full practice authority to nurse practitioners, and 

 that this become the norm across the nation.

The fellowship consisted of 12 months of clinical rotations as well as 3 semesters of coursework and learning opportunities. It allowed fellows to collaborate with experts in important oncology specialties, such as genomics, infectious disease, palliative care, hematology, medical oncology, and survivorship. Individuals who were accepted into and enrolled into the fellowship program could also enroll in Azusa Pacific University’s Doctorate of Nursing Practice program.

“The exposure and collaboration with clinical experts in each specialty provided an experience and a wealth of knowledge that I will carry into my career moving forward,” Butcher said. “Participation in this fellowship has direct implications on the improvement of nursing practice, investing the education of APPs.”

Fellows were expected to reach a number of milestones that would not only help evaluate the program, but also promote their growth as a provider. They included:

Clinical rotations in hematology, medical oncology, supportive medicine, and the department of medicine

Obtaining an ASCO Advanced Practitioner Certificate

Presentation at a local or national conference

Graduation from Azusa Pacific University’s Post-Masters ONP Certificate program

“It is well known that the number of individuals with cancer and cancer survivors continues to grow. And with this growth, advanced practice providers are relied upon to ensure that patients receive high-quality care,” Butcher said.

Butcher K. Oncology Nurse Practitioner Fellowship: A Reflection on the Educational Benefits of a Postdoctoral Fellowship Program. Presented at: 46th Annual ONS Congress. April 20, 22, 27, 29, 2021. Virtual.

Nurse practitioners are more valuable than ever in the world of cancer care.

NP Fellowship Helps Prepare Providers for Oncology Career

Due to the COVID-19 pandemic, many patients’ and survivors’ care has changed, but one nurse and her team sought to make this population more comfortable and safe during these times with virtual visits.

COVID-19 Pandemic Shows ‘Silver Lining’ of Virtual Visits for Veterans Who Have Survived Cancer

Breast cancer survivors may experience an increase in fear of recurrence after undergoing genomic testing that reveals risk. 

Genomic Testing May Increase Fear of Recurrence

Early research showed an improvement in provider recommendations of care for patients with breast cancer based on eight guideline metrics.

A New Care Delivery Model May Positively Impact Care Referrals for Patients with Breast Cancer

The FDA has granted an accelerated approval to loncastuximab tesirine (Zynlonta) for the treatment of adult patients with relapsed/refractory large B-cell lymphoma following 2 or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low-grade lymphoma, and high-grade B-cell lymphoma.

FDA Approves Loncastuximab Tesirine for Relapsed/Refractory DLBCL

Survivors of cancer go through coping during the first year after treatment and require specific resources. But these were limited due to the pandemic resulting in survivors self-coping with known mechanisms. 

Older Cancer Survivors Struggle to Cope During the COVID-19 Pandemic

The current scale often used to measure nurse quality of life may be missing some key factors, according to recent research. 

Improving Nurse QOL May Lead to Better Outcomes

The use of a smartphone mobile app showed that patients with cancer had higher adherence to oral chemotherapy regimens, especially when it came to safely monitoring chemotherapy toxicity and symptoms in real time.  

Smartphone Mobile Apps Could Help Patients Monitor and Adhere to Oral Chemotherapy 

The FDA approved dostarlimab (Jemperli) for the treatment of patients with recurrent or advanced endometrial cancer that progressed on or after platinum-containing chemotherapy and whose cancer is DNA mismatch repair deficient (dMMR), as determined by an FDA-approved test.










FDA Approves Dostarlimab for dMMR Advanced Endometrial Cancer

A walking program dramatically increased the number of steps walked by patients being treated for hematologic malignancies. 

Walking Program Improves Ambulation in Patients with Hematologic Cancer

CE lesson worth 1 contact hour that is intended to advanced practice nurses, registered nurses, and other healthcare professionals who care for patients with cancer.

Top Medical News

FDA Approves Frontline Pembrolizumab for HER2+ Gastric, GEJ Cancer

Reduce Recurrence in Early-Stage NSCLC

Expert Talks Ethics in Oncology Nursing

Rolling Submission Completed for Surufatinib to Treat Advanced NETs

NP Fellowship Helps Prepare Providers for Oncology Career

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