Precision Pfizer drug leads to “unprecedented” survival in colorectal cancer, data from ASCO shows
Precise Oncology The Pfizer drug now has clinical data that suggests it can help patients with colorectal cancer live longer, and researchers say researchers may change the way doctors treat those diseases that show specific genetic characteristics targeted by the therapy.
Patients receiving Pfizer drug Braftovi and standard of care colorectal cancer therapy were 51% lower than those receiving standard of care chemotherapy. Dr. Elena Elez, head of the colorectal cancer group at the Vall d’Hebron Institute of Oncology in Barcelona, said in a briefing with reporters earlier this week that the results of these Phase 3 were both statistically significant and clinically significant. The data is scheduled to be presented Friday afternoon at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.
Braftovi is a kinase inhibitor, a small molecule designed to inhibit enzymes that drive cancer growth when mutations occur. The Pfizer drug is specially designed to block enzymes called BRAF V600E. It was first approved for the use of this genetic feature in 2018 to treat advanced melanoma.
Late last year, the FDA expanded Braftovi’s tag to include first-line treatment for colorectal cancer using the BRAF V600E mutation. Accelerated approval is based on the results of Phase 3, showing a target response rate of 61%. In this trial, progression-free survival and overall survival are the benchmarks for confirmation that FDA approved in this indication. Positive preliminary results were released in February. The ASCO demo will provide specific numbers.
The third phase of the study tested Braftovi, an Eli Lilly drug used with chemotherapy, as standard treatment for colorectal cancer. Eli Lilly is an antibody that blocks cancer targets called EGFR. Pfizer and Eli Lilly drugs were tested, without standard chemotherapy, and compared with nursing chemotherapy with or without Roche Cancer Cancer Drug Avastin.
Patients with Braftovi, Erbitux and chemical arms live longer and have no cancer worsening. In the study drug group, this progression-free survival rate was 12.8 months, compared with 7.1 months in the control group. But progress-free survival is not always associated with improving overall survival. Elez noted that Braftovi’s results showed that the median overall survival was 30.3 months, compared with 15.1 months in the control group.
“Given the poor historical prognosis of metastatic colorectal cancer with BRAF mutations, this survival data is unprecedented,” Elez said.
For patients with Pfizer and Eli Lilly drugs plus chemotherapy, the most common side effects include nausea, anemia, and diarrhea. Elez said these effects are consistent with known drugs and are manageable. She added that Pfizer’s Braftovi, along with Erbitux and Standard Chemo, could become the new standard of care for practice to carry patients with colorectal cancer with BRAF V600E mutations.
In the same briefing as journalists, ASCO expert Dr. Joel Saltzman described the trial as another victory towards precision oncology. He said only about 10% of patients with colorectal cancer have mutations resolved by Braftovi, but significant improvements in response rates and overall survival may translate into their improved quality of life. Saltzman added that the study highlights the importance of advanced biomarker testing to identify the best treatments, which has played a role in other indicators.
“When we look at patients who are now suffering from colorectal cancer, we don’t think of them as a disease,” said Salzman, a medical oncologist at Cleveland Clinic. “With biomarker testing, we now have three different diseases, and it’s even important to know – their BRAF status RAS mutation status and the stable status of microsatellites – to help determine a reasonable treatment option.”
Braftovi comes from Pfizer’s 2019 acquisition of Biopharma. In addition to obtaining approved uses for melanoma and colorectal cancer, the drug is also approved for the treatment of advanced cases of non-small cell lung cancer with BRAF V600E mutations. In 2024, Pfizer reported sales of the product at $607 million in all its approved signs, up more than 27% from the previous year’s sales.
Photo: Dominick Reuter / AFP, by Getty Images
