2022 ASCO Annual Meeting: Improving Standard Care for Advanced Pancreatic Cancer and Older Adults with Mantle Cell Lymphoma

2022 ASCO Annual Meeting; #ASCO22
June 3, 2022
Greg Guthrie, ASCO staff

The theme of the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting is Advancing Equitable Cancer Care Through Innovation. From June 3 to 7 in Chicago, Illinois, and online, cancer researchers and clinicians from around the world will gather to discuss the latest research and how to ensure that all people receive the cancer care they need.

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Some of the notable research that will be presented today includes: 

Adding nimotuzumab to gemcitabine helps some people with advanced pancreatic cancer live longer

Who does this study affect? People with advanced pancreatic cancer and no mutation in the tumor’s KRAS gene.   

What did this study find? The phase III NOTABLE clinical trial showed that adding a targeted therapy called nimotuzumab to a standard chemotherapy called gemcitabine helped people with KRAS wild-type, locally advanced or metastatic pancreatic cancer live longer. In KRAS wild-type pancreatic cancer, the tumor’s KRAS gene is found in its natural, unchanged form. The majority of pancreatic cancers do not have wild-type KRAS genes. Knowing whether a tumor has a wild-type or mutated KRAS gene can help determine which treatments may be available.

Nimotuzumab is an antibody that targets the epidermal growth factor receptor (EGFR) on a cell’s surface and can slow or stop the growth of tumor cells that express higher levels of EGFR. This medication is used in China to treat nasopharyngeal cancer, a kind of head and neck cancer, but it is not approved by the U.S. Food and Drug Administration (FDA).

This study was conducted in China with 92 people with KRAS wild-type, advanced pancreatic cancer. The study participants were evenly divided into 2 groups. The first group received nimotuzumab followed by gemcitabine (Gemzar). Gemcitabine is a standard treatment for pancreatic cancer given in China, the United States, and elsewhere. The second group received gemcitabine plus a placebo (learn more about placebos in cancer clinical trials).

Participants in the group receiving nimotuzumab plus gemcitabine lived for a median of nearly 11 months, while those who received gemcitabine plus a placebo lived for a median of 8.5 months. The median is the midpoint, meaning that half the participants lived longer than the median and the other half did not. At 1 year, about 44% of the participants who received nimotuzumab were still alive, compared with nearly 27% of the participants who did not receive nimotuzumab. At 3 years, about 14% of those who received nimotuzumab were still alive, compared with just under 3% of those who did not receive nimotuzumab. Nimotuzumab plus gemcitabine stopped or slowed the cancer from growing for a median of 4.2 months. Gemcitabine without the nimotuzumab stopped or slowed the cancer from growing for a median of 3.6 months.

The researchers saw no difference in the rates of side effects between the 2 treatment groups. The most common serious side effects in those receiving the nimotuzumab combination were low levels of platelets and white blood cells.  

What does this mean for patients? For the 10% to 15% of pancreatic cancers that have a wild-type KRAS gene, nimotuzumab added to gemcitabine chemotherapy may change the standard of care.

"We believe our NOTABLE trial will be a breakthrough in the field of pancreatic cancer. The outcomes in this trial may bring new hope to patients with KRAS wild-type pancreatic cancer.

— lead study author Shukui Qin, MD
Nanjing University of Chinese Medicine
Nanjing, China

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Adding ibrutinib to treatment improves progression-free survival by 50% for older adults with mantle cell lymphoma 

Who does this study affect? People 65 or older who have mantle cell lymphoma, a type of non-Hodgkin lymphoma

What did this study find? Results from the phase III SHINE clinical trial found that adding ibrutinib (Imbruvica) to the current standard of care treatment for newly diagnosed mantle cell lymphoma improved progression-free survival (PFS) by 50% over standard care alone. PFS is the length of time during and after treatment that the cancer does not grow or spread further.

Mantle cell lymphoma is a type of non-Hodgkin lymphoma that begins in the B cells. It most often appears in people older than 60 and is much more common in men than in women. The side effects of other common treatments for lymphoma, such as intensive chemotherapy or bone marrow/stem cell transplantation, can be a significant barrier to using them so there is need for other effective treatments in mantle cell lymphoma for this age group.

Standard care for mantle cell lymphoma in older adults uses a combination of a chemotherapy called bendamustine (Treanda) combined with a targeted therapy called rituximab (Rituxan). If the combination puts the lymphoma in remission, it can be followed with a longer treatment with rituximab alone to prevent the cancer from coming back (this is called maintenance therapy). In this study, the researchers wanted to see if adding ibrutinib to the combination of bendamustine plus rituximab, followed by rituximab maintenance therapy, made the treatment regimen more effective. Ibrutinib is a type of targeted therapy called a Bruton’s tyrosine kinase inhibitor that is approved by the FDA to treat several B-cell lymphomas.

This study included 523 people aged 65 or older with newly diagnosed mantle cell lymphoma, divided into 2 groups. Participants in both groups received standard care, which was bendamustine plus rituximab, followed by rituximab maintenance therapy if the cancer responded to treatment. There were 261 participants in the group that also received ibrutinib and 262 participants in the group that received a placebo.

The researchers found that the median PFS was nearly 81 months in those who received ibrutinib plus standard care, compared with about 53 months in those who received standard care alone. The complete response rate, where there were no signs of the cancer anywhere in the body in scans or tests, was about 66% in the ibrutinib group and about 58% in the standard care group. There were 52 participants in the ibrutinib group who needed additional treatment for the lymphoma, compared with 106 participants in the standard care group. However, the researchers saw no difference between the two groups in overall survival, which is the length of time from diagnosis or the start of treatment that patients are still alive.

Most of the participants in both groups experienced higher grade side effects, about 82% of those in the ibrutinib group and about 77% of those in the standard care group. Quality of life measures were similar for people in both groups.  

What does this mean for patients? Adding ibrutinib to standard care for people older than 65 with newly diagnosed mantle cell lymphoma improves PFS.

The SHINE study is the first international phase III trial to show a positive impact of ibrutinib combined with standard-of-care treatment in this disease. The progression-free survival is substantially longer than the common treatment options used today, which is an important clinical advancement.

— lead study author Michael Wang, MD
The University of Texas MD Anderson Cancer Center
 Houston, Texas

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