publication date: Jun. 5, 2020

Clinical Roundup

ACS study defines lost earnings for black cancer patients

A new American Cancer Society study puts a price tag on racial disparities in cancer mortality, finding that $3.2 billion in lost earnings would have been avoided in 2015 if non-Hispanic blacks had equal years of life lost from cancer deaths and earning rates as NH whites.

The study appears in JNCI Cancer Spectrum.

Investigators, led by Jingxuan Zhao, compared person-years of life lost and lost earnings due to premature cancer deaths by race/ethnicity. PYLL was calculated using national cancer death and life expectancy data. That was combined with annual median earnings to generate lost earnings. PYLL and lost earnings were then compared among individuals who died at age 16-84 years due to cancer by racial/ethnic groups: NH white, NH black, NH Asian or Pacific Islander, and Hispanic.

They found that in 2015, age-standardized lost earning rates (per 100,000 person-years) were $34.9 million for NH whites, $43.5 million for NH blacks, $22.2 million for APIs, and $24.5 million for Hispanics. NH blacks had higher age-standardized PYLL and lost earning rates than NH whites for 13 out of 19 cancer sites studied.

“If age-specific PYLL and lost earning rates for NH blacks were the same as those of NH whites, 241,334 PYLLs and $3.2 billion lost earnings (22.6% of the total lost earnings among NH blacks) would have been avoided,” the authors write. “Improving equal access to effective cancer prevention, screening, and treatment will be important in reducing the disproportional economic burden associated with racial/ethnic disparities,” they conclude.


Keytruda monotherapy significantly reduces risk of disease progression, death in colorectal cancer

A phase III trial evaluating Keytruda monotherapy demonstrated a significant reduction in risk of disease progression in death in microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) unresectable or metastatic colorectal cancer.

Results from KEYNOTE-177, a phase III trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, showed that Keytruda monotherapy reduced risk of disease progression or death by 40% (HR=0.60 [95% CI, 0.45-0.80; p=0.0002]) and showed a median progression-free survival of 16.5 months compared with 8.2 months for patients treated with chemotherapy (investigator’s choice of mFOLFOX6 or FOLFIRI, with or without bevacizumab or cetuximab), a current standard of care in this patient population.

As previously announced, the study will continue without changes to evaluate overall survival, the other dual primary endpoint. These results were selected for presentation on Sunday, May 31, 2020 in the plenary session of the virtual scientific program of the 2020 American Society of Clinical Oncology annual meeting (Abstract #LBA4).

“For many years, the standard of care for the first-line treatment of patients with MSI-H colorectal cancer has been the combination of mFOLFOX6 plus bevacizumab. This is the first time a single-agent, anti-PD-1 therapy demonstrated a superior, statistically significant and clinically meaningful improvement in progression-free survival, compared to chemotherapy for these patients,” Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, said in a statement.

“Keytruda monotherapy significantly reduced the risk of disease progression or death by 40% versus standard of care chemotherapy, with fewer treatment-related adverse events observed, in patients with MSI-H metastatic colorectal cancer. Keytruda also demonstrated a long-term, durable response that lasted over two years for those who responded to treatment,” Thierry Andre, professor of medical oncology at Sorbonne University, and head of the Medical Oncology Department in St. Antoine Hospital, Assistance Publique Hôpitaux de Paris, said in a statement.

In May 2017, Keytruda was the first cancer therapy approved by FDA for use based on a biomarker, regardless of tumor type, in previously treated patients with MSI-H or dMMR solid tumors.


Alecensa increases OS rate in ALK-positive NSCLC

The phase III ALEX study demonstrated an increased five-year survival rate with Alecensa (alectinib), compared with crizotinib, in people living with anaplastic lymphoma kinase-positive non-small cell lung cancer.

These data confirm the longer-term efficacy of Alecensa already demonstrated across three phase III clinical trials. Full findings were presented at the ASCO annual meeting on May 29.

“Importantly, these data show clinically meaningful benefit in people with or without central nervous system metastases,” Levi Garraway, chief medical officer and head of global product development at Roche, said in a statement.

The updated results from the ALEX study show a five-year survival rate of 62.5% (95% CI: 54.3-70.8) in the Alecensa treatment group, versus 45.5% (95% CI: 33.6-57.4) with crizotinib. Despite longer median treatment duration, the safety profile of Alecensa remains favourable and consistent with previous data, with no new safety signals identified. The overall survival data, which are not yet mature, show a benefit in patients with CNS metastases at baseline (42% reduction in the risk of death versus crizotinib (95% CI: 0.34-1.00)), as well as in those without CNS metastases at baseline (24% reduction in the risk of death versus crizotinib (95% CI: 0.45-1.26)).

These data follow on from the final, mature progression-free survival data from the ALEX study, presented at the European Society for Medical Oncology congress in September 2019, which demonstrated a reduced risk of disease worsening or death by 57% (hazard ratio=0.43, 95% CI: 0.32–0.58) with Alecensa, versus crizotinib, in ALK-positive NSCLC.2 The updated data confirm the superior efficacy and tolerability of Alecensa in comparison to crizotinib.


Xtandi significantly extends OS in men with non-metastatic CRPC

Xtandi plus androgen deprivation therapy reduced the risk of death in the phase III PROSPER trial evaluating Xtandi (enzalutamide) plus ADT versus placebo plus ADT in men with non-metastatic castration-resistant prostate cancer.

Xtandi and ADT reduced risk of death by 27% (n=1,401; hazard ratio [HR]=0.73; [95% confidence interval [CI]: 0.61-0.89]; p=0.001) compared to placebo plus ADT. The median OS was 67.0 months (95% CI: 64.0 to not reached) for men who received Xtandi plus ADT compared to 56.3 months (95% CI: 54.4 to 63.0) with placebo plus ADT. OS was a key secondary endpoint of the trial.

Xtandi is sponsored by Pfizer Inc. and Astellas Pharma Inc.

These data were simultaneously published online in the New England Journal of Medicine and presented during the virtual scientific program of the 2020 ASCO annual meeting (Abstract #5515).

In findings published in the New England Journal of Medicine in 2018, the PROSPER trial met its primary endpoint of metastasis-free survival, demonstrating a significant reduction in the risk of developing metastasis or death with Xtandi plus ADT compared to ADT alone in men with nmCRPC (HR=0.29 [95% CI: 0.24-0.35]; p<0.001). MFS was measured as the time from patients entering the trial until their cancer was radiographically detected as having metastasized, or until death, within 112 days of treatment discontinuation.

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