Leighanne Hartman, MSN, RN, AGNP-C, CHPN, CCRC, the clinical research nurse assigned to the MOUNTAINEER trial on day one (2017) made a special trip to see Elle at her infusion appointment on June 10, 2021. It had been over two years since they’d last seen each other and they had a lot to catch up on — new dogs, growing kids, and summer plans. For Hartman, the experience of working on MOUNTAINEER for two years and meeting Elle inspired a career change. In 2019, she went back to school to earn nurse practitioner certification so she could engage with more hands-on patient care.“Upon first meeting Elle, she gave off such a positive attitude, exuding optimism, while calling on her faith to sustain her. I was in awe of Elle’s determination to live her life, resolute in finding a treatment to prolong her life and put her cancer in remission,” said Hartman, who now works on Unit 9300, an inpatient unit for critically ill cancer patients.
Mountaineer: A Homegrown Story of Survival & Promise
Updated
Global biotech company Seagen Inc. announced positive topline results last month of a pivotal phase 2 clinical trial (called MOUNTAINEER) of tucatinib in combination with trastuzumab in HER2-positive metastatic colorectal cancer. Both drugs are used in breast cancer, a type of cancer where HER2 amplification is common. HER2 amplification is uncommon, however, in colorectal cancer.
The idea to test these drugs in HER2-positive colorectal cancer patients was initiated by Duke Cancer Institute GI oncologist and co-leader of DCI's Precision Cancer Medicine and Investigational Therapeutics Research Program, John Strickler, MD, who first reached out to Seagen (then Cascadian Therapeutics and the maker of tucatinib) around 2015.
On August 8, 2017, the first patient nationwide to be accrued — Elle Charnisky — began the trial at DCI.
Now a 5-year metastatic colorectal cancer survivor, Charnisky is still going strong and most recently shared her story at the DCI 50th Anniversary celebration held on April 14, 2022.
Strickler will present the full data at the European Society for Medical Oncology (ESMO) World Congress on Gastrointestinal Cancer in Barcelona, Spain — to be held June 29 through July 2, 2022. According to Seagen, "data from this trial will form the basis of a planned supplemental New Drug Application to the FDA under the FDA’s Accelerated Approval Program."
UPDATE (January 19, 2023): FDA Approval
Associate Professor of Medicine and GI oncologist John Strickler, MD, and team's milestone work on the clinical trial "MOUNTAINEER" has led to the first FDA-approved treatment regimen for patients with HER2+ metastatic colorectal cancer. Tucatinib (Tukysa, Seagen Inc.), in combination with trastuzumab for RAS wild-type HER2-positive unresectable or metastatic colorectal cancer that has progressed following fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, was granted accelerated approval.
READ MORE about Elle's Journey and the History of Mountaineer
SURVIVOR Colorectal cancer survivor Elle Charnisky, 41, finds respite in the Bernstein Family Garden. The rooftop garden is accessible from the Oncology Treatment Center waiting room (Duke Cancer Center Level 4, June 10, 2021, photo by Julie Poucher Harbin)
In 2017, Elle Charnisky, then a 37-year-old mother of two children under five, had 7 months to live. She was nearly out of options.
Elle Charnisky (in a black & white shirt at center) and her care team celebrate her survival at Duke Cancer Institute's 50th Anniversary commemoration, held on the lawn of Duke Cancer Center on April 14, 2022. (photo by Drawbridge Media)
In Her Own Words, April 2022
"When we sat down in the office of Dr. John Strickler, who is truly one in a million, we had a sense that our lives were never going to be the same... "
Charlotte-area resident Vickie Johnson, 72, was diagnosed with colon cancer in 2018 after seeking care twice for abdominal pain. First, she was diagnosed with appendicitis and had her appendix out. Then, when her pain persisted beyond the recovery period, she received a new diagnosis. A scan at the ER showed a possible tumor. She went back to her appendix surgeon, had the mass in her colon removed, and was referred to a hospital oncologist. He referred her to a second surgeon who performed an even more aggressive surgery to remove all the remaining cancer in her colon and got her started on chemotherapy.Unfortunately, after each chemotherapy infusion she experienced severe chest pain. As she described it, “terrible spasms like I was having a heart attack.” Her oncologist didn’t have a plan b. “Finally, he said ‘I'm sorry, there's nothing I can do. We'll just test your blood every so often and get a scan every six months,’” Johnson shared. She wasn’t ready to give up, and as it turned out she didn’t need to.Johnson’s next area oncologist — Justin Favaro, MD, PhD — who'd done his medical training at Duke, brought a cardio-oncologist onboard the care team. The two providers tweaked the chemotherapy regimen she’d been on with the first oncologist; adjusting the dosage so her heart would be able to tolerate it. That worked, but successive treatments didn’t make any headway against her cancer.Johnson had begun 2019 in treatment for newly diagnosed colon cancer and ended that year with the death of her husband and progression of her cancer. During 2020, she’d endured another chemotherapy regimen but with no success. Cancer metastases remained in her liver and her lungs.Patients with metastatic colorectal cancer who have progressed on standard chemotherapy receive limited benefit from the available standard of care options. Johnson had genomic testing done and it turned out her cancer was hardwired with a KRAS G12C mutation, an alteration found in 3 to 4% of all metastatic colorectal cancer cases. Favaro said there was one more option.In the summer of 2021, he referred Johnson for enrollment in CodeBreaK 101, an early-stage clinical trial (phase 1b/2) at Duke Cancer Institute testing a new approach to treating KRAS G12C-mutated solid tumor cancers — a new KRAS G12C inhibitor drug (sotorasib) in combination with other anti-cancer therapies of choice, including FDA-approved antibodies, immunotherapy, and chemotherapy drugs. DCI was one of the first institutions worldwide to open this trial, which had launched in December 2019.Duke Cancer Institute GI medical oncologist and Associate Professor of Medicine John Strickler, MD, was Duke site principal investigator. Strickler is a colon cancer specialist who co-leads the DCI Precision Cancer Medicine and Investigational Therapeutics Research Program and the Molecular Tumor Board.Johnson said she had “no hesitation” about her decision and was grateful when she qualified for recruitment to the study under the care of Strickler.“This was the option. Nothing else was working,” Johnson recalled.
Charlotte-area resident Vickie Johnson, 72, was diagnosed with colon cancer in 2018 after seeking care twice for abdominal pain. First, she was diagnosed with appendicitis and had her appendix out. Then, when her pain persisted beyond the recovery period, she received a new diagnosis. A scan at the ER showed a possible tumor. She went back to her appendix surgeon, had the mass in her colon removed, and was referred to a hospital oncologist. He referred her to a second surgeon who performed an even more aggressive surgery to remove all the remaining cancer in her colon and got her started on chemotherapy.Unfortunately, after each chemotherapy infusion she experienced severe chest pain. As she described it, “terrible spasms like I was having a heart attack.” Her oncologist didn’t have a plan b. “Finally, he said ‘I'm sorry, there's nothing I can do. We'll just test your blood every so often and get a scan every six months,’” Johnson shared. She wasn’t ready to give up, and as it turned out she didn’t need to.Johnson’s next area oncologist — Justin Favaro, MD, PhD — who'd done his medical training at Duke, brought a cardio-oncologist onboard the care team. The two providers tweaked the chemotherapy regimen she’d been on with the first oncologist; adjusting the dosage so her heart would be able to tolerate it. That worked, but successive treatments didn’t make any headway against her cancer.Johnson had begun 2019 in treatment for newly diagnosed colon cancer and ended that year with the death of her husband and progression of her cancer. During 2020, she’d endured another chemotherapy regimen but with no success. Cancer metastases remained in her liver and her lungs.Patients with metastatic colorectal cancer who have progressed on standard chemotherapy receive limited benefit from the available standard of care options. Johnson had genomic testing done and it turned out her cancer was hardwired with a KRAS G12C mutation, an alteration found in 3 to 4% of all metastatic colorectal cancer cases. Favaro said there was one more option.In the summer of 2021, he referred Johnson for enrollment in CodeBreaK 101, an early-stage clinical trial (phase 1b/2) at Duke Cancer Institute testing a new approach to treating KRAS G12C-mutated solid tumor cancers — a new KRAS G12C inhibitor drug (sotorasib) in combination with other anti-cancer therapies of choice, including FDA-approved antibodies, immunotherapy, and chemotherapy drugs. DCI was one of the first institutions worldwide to open this trial, which had launched in December 2019.Duke Cancer Institute GI medical oncologist and Associate Professor of Medicine John Strickler, MD, was Duke site principal investigator. Strickler is a colon cancer specialist who co-leads the DCI Precision Cancer Medicine and Investigational Therapeutics Research Program and the Molecular Tumor Board.Johnson said she had “no hesitation” about her decision and was grateful when she qualified for recruitment to the study under the care of Strickler.“This was the option. Nothing else was working,” Johnson recalled.