Colleen Moretti

Treatment with derazantinib in patients with inoperable or advanced intrahepatic cholangiocarcinoma and FGFR2 gene fusions demonstrated promising disease control, according to a press release from Basilea Pharmaceutica announcing results from an analysis of a phase 2 study.

“This supports the relevance of derazantinib in a group of patients with (inoperable or advanced intrahepatic cholangiocarcinoma) where there has been very limited clinical evidence of successful treatment with other FGFR inhibitors and confirms the broad potential of derazantinib as a monotherapy for the treatment of (inoperable or advanced intrahepatic cholangiocarcinoma) patients with diverse FGFR2 gene aberrations,” said Dr. Marc Engelhardt, chief medical officer at Basilea Pharmaceutica, in the release.

The interim analysis consisted of 14 evaluable patients with locally advanced or inoperable cholangiocarcinoma with at least one tumor assessment after the start of the study.

The disease control rate (percentage of patients who have achieved complete response, partial response and stable disease) was 79%. This included one patient who had a complete response, one patient with an unconfirmed partial response and nine patients with a best response of stable disease.

In addition, at least eight patients met the primary endpoint of progression-free survival (the time during and after treatment when a patient lives with the disease without worsening) of at least three months. Progression-free survival in the other patients will be assessed at a later analysis.

“We are very pleased with the positive interim results or this cohort of (inoperable or advanced intrahepatic cholangiocarcinoma) patients with FGFR2 gene mutations or amplifications,” Engelhardt said in the release. “The clinical benefit with derazantinib is similar to that reported for (inoperable or advanced intrahepatic cholangiocarcinoma) patients with FGFR2 gene fusions earlier this year.”

In the release, Engelhardt added that additional results are tentatively slated to be released next year.

“This outcome is very encouraging and further strengthens the evidence for the differentiation of derazantinib versus other FGFR inhibitors both from the efficacy and safety perspective,” Engelhardt said in the release. “We are now progressing the study to the next stage and expect topline results for cohort 2 in the first half of 2022.”

In a previous study with 29 patients, derazantinib showed antitumor activity with a favorable tolerability profile in this patient population with an overall response rate (percentage indicating patients with a partial or complete response to treatment) of 20.7% and median progression-free survival of 5.7 months. Common side effects included weakness/fatigue (69%), eye toxicity (41.4%) and increased phosphate levels in blood (75.9%). Side effects considered severe or worse occurred in 27.6% of patients.

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Interim results from a phase 2 study demonstrated that patients inoperable or advanced intrahepatic cholangiocarcoma and a FGFR2 gene mutation had a disease control rate of 79% when treated with derazantinib.

Derazantinib May Demonstrate Promising Disease Control in Some Patients With Cholangiocarcinoma

Keytruda (pembrolizumab) does not significantly decrease health-related quality of life in patients with resected, high-risk stage 3 melanoma compared to placebo, according to data published in 

“Given the need for safe and effective adjuvant therapies, the assessment of (health-related quality of life) is increasingly important, in part because of serious (side effects) associated with melanoma drug therapies,” the study authors wrote.

Previously, it was reported in a phase 3 trial that recurrence-free survival (the length of time after primary treatment ends without any signs or symptoms of cancer) was improved in patients with resected stage 3 melanoma who were treated with Keytruda compared with placebo.

The trial included 1,019 patients with previously untreated stage 3 resected cutaneous melanoma. Patients received either Keytruda (514 patients) or placebo (505 patients). Factors of interest included health-related quality of life (an individual’s or group’s perceived mental and physical health over time) and overall health. Follow-up was conducted for a median of 15.1 months.

Health-related quality of life survey compliance was 93.6% at the start of the study. This decreased over time, with greater than 70% compliance during the first year and greater than 60% afterwards for both treatment groups.

When the study began, overall health/quality of life scores were similar in both groups and remained stable through time. The difference between the two groups during treatment was –1.1 points and was –2.2 points after treatment. There was also a difference of –2.2 points after two years.

“These differences are within the five-point clinical relevance threshold for the (the questionnaire used to assess the patients physical, psychological and social quality of life) and are therefore clinically non-significant,” the study authors wrote.

Researchers noted that although severe or worse side effects occurred more often in the Keytruda group versus the placebo group, this was not reflected in the health-related quality of life reports.

“The results of our exploratory (health-related quality of life) endpoint analysis demonstrated that (Keytruda) had no clinically relevant effect on the (global health/quality of life) scale compared with placebo, showing that prolonged recurrence-free survival does not necessarily come at the price of reduced (health-related quality of life),” the study authors concluded.

Patients with melanoma treated with Keytruda had improved recurrence-free survival without an effect on their quality of life.

Prolonging Recurrence-Free Survival With Keytruda Does Not Come at the Price of Reduced Quality of Life for Patients with Melanoma

Treatment with Venclexta (venetoclax) plus a hypomethylating agent improved complete remission with or without count recovery and median survival in patients with acute myeloid leukemia, according to data published by the 

This effect was observed in patients both with de novo or relapsed/refractory disease, according to the study.

The multicenter study consisted of 32 patients (median age, 69 years; 59% men) with blast-phase myeloproliferative neoplasm.

“Blast phase transformation is the most feared complication in patients with myeloproliferative neoplasms, and its 20-years estimated incidence was approximately 9% for primary myelofibrosis, 4% for polycythemia vera and 3% for essential thrombocythemia,” the study authors wrote.

Twelve patients received Venclexta in combination with azacitidine and 20 patients received Venclexta with Dacogen (decitabine). Patients received treatment either upfront (23 patients) or after failing another induction therapy (9 patients), which did not affect response.

Fourteen patients (44%) achieved complete remission (the disappearance of all signs of cancer in response to treatment) with or without count recovery. This was more likely in patients with the absence of pre-leukemic polycythemia vera/post-polycythemia vera myelofibrosis phenotype, complex karyotype or K/NRAS mutations. Other responses included morphological leukemia free state in two patients (6%) and partial response in four patients (13%).

Four out of 21 patients (19%) with K/NARS mutation or complex karyotype achieved complete remission with or without count recovery compared to seven out of eight patients (88%) without.

Researchers compared the 32 patients who received combination therapy in this study to a previous study in which 26 patients only received a hypomethylating agent. Complete remission rates with or without recovery were more favorable in patients treated with a combination of Venclexta with hypomethylating agent (44%) than with a hypomethylating agent alone (4%). This was also observed with median survival at eight months in the combination group and 5.5 months in the hypomethylating agent alone group.

“In the meantime, more recent studied suggest the value of (Venclexta)-based combination chemotherapy might extend to more intensive settings that might be applicable to patients with (blast phase myeloproliferative neoplasm),” the study authors concluded. “Taken together, the observations from the current study are encouraging in terms of the potential value of (Venclexta plus a hypomethylating agent) in (blast phase myeloproliferative neoplasm), as a bridge to (allogenic hematopoietic stem cell transplant), with room for improvement.”

Compared to a hypomethylating agent alone, combining the agent with Venclexta improved complete remission rates in patients with blast-phase myeloproliferative neoplasm.

Venclexta With a Hypomethylating Agent Shows Promise for Patients with Acute Myeloid Leukemia

Virtual visits from cancer care coordinators could be utilized even after the COVID-19 pandemic due to its results of overall satisfaction, reduced stress and convenience in veterans who have survived cancer, according to a virtual poster presentation at the Oncology Nursing Society Congress.

Due to social distancing requirements during the COVID-19 pandemic, many veterans who are cancer survivors experienced changes in treatment protocols and schedules. This resulted in higher levels of stress and anxiety about changes in their outcome and survival, on top of stress about their cancer diagnosis, noted Janice Schwartz, an oncology certified nurse at the New Mexico VA Healthcare System, said during the presentation.

“As a cancer care coordinator, my role morphed abruptly in March 2020. I was faced with calling veterans living with a cancer diagnosis to advise them of cancelled procedures, visits and surgeries due to the COVID-19 pandemic,” said Schwartz. “I found veterans living with a cancer diagnosis were experiencing new stressors. Already experiencing anxiety related to the diagnosis of cancer that we are all familiar with, they now face limitations of (COVID-19) further impacting their lives.”

Providers found a new way to connect with this population to improve communication through virtual visits to potentially decrease stress about COVID-19 and improve patients’ satisfaction regarding their survivorship care.

“I have found maintaining visual contact with a veteran allows them to feel connected, to know that we are still here for them and has improved patient’s satisfaction,” Schwartz said.

Prior to the virtual appointments, veterans were emailed instructions on how to use the platform and scheduling on a personal laptop, tablet, computer or smartphone. Upon completion of the appointment, they were emailed a survey, of which 100% were returned.

During the virtual appointments, veterans were given reassurance regarding cancer treatment and recommendations, in addition to COVID-19 safety measures and processes to decrease possible exposure.

A total of 95% of the veterans reported an overall decrease in anxiety after the virtual appointment. The appointments decreased COVID-19 related stress in 90% of veterans and led to improved patient satisfaction in 96% of veterans.

The virtual appointments resulted in the following:

overall convenience (less time off work, avoidance of travel and expenses, not having to search for parking and ability to stay safely at home),

decreased anxiety (decreased post-traumatic stress disorder symptoms, less worry and less nervousness),

decreased stressors (ability to stay safety at home, understanding safety measures implemented in the hospital and review of recommended)

and improved satisfaction (personalized visit vs. phone call, ability to see their chart and reports through shared screen options and requested to have virtual post COVID-19).

Limitations of the virtual appointments included requiring an electronic device with a camera, connection to internet, Apple misfunctions, remembering usernames and passwords.

“I’ve learned by saying that perhaps if we look to the end of the rainbow and search for the silver lining of (COVID-19), we would see the many advances in care such as virtual platforms that will continue to improve care and decrease barriers for our veterans long after (the COVID-19 pandemic),” Schwartz concluded.

Virtual visits during the COVID-19 pandemic improved satisfaction and convenience, as well as reduced stress and anxiety in veterans who have survived cancer.

Colleen Moretti

Derazantinib May Demonstrate Promising Disease Control in Some Patients With Cholangiocarcinoma

Prolonging Recurrence-Free Survival With Keytruda Does Not Come at the Price of Reduced Quality of Life for Patients with Melanoma

Venclexta With a Hypomethylating Agent Shows Promise for Patients with Acute Myeloid Leukemia

Nurse Finds ‘Silver Lining’ for Survivors of Cancer with Virtual Visits

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