Galectin Therapeutics (GALT) says new clinical trial data disclosed Thursday suggest its experimental cancer drug improves the efficacy of Merck’s blockbuster immunotherapy therapy Keytruda when the two drugs are used together to treat patients with advanced melanoma.
No, the new Galectin data — what little there are — show no such thing. It’s more reasonable to conclude these new data show Galectin’s drug to be a placebo.
Galectin is a small biotech company, headquartered in a north Atlanta suburb, with a reputation going back years for making overly promotional claims about its drug pipeline. Most recently, Galectin has been trying to sell investors on the idea that its experimental drug, GR-MD-02, could be effective against two disparate diseases — the chronic fatty liver disease known as NASH and cancer.
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This article leaves out important facts. First, the study found a decrease in myeloid-derived suppressor cells (MDSC) which help cancer cells to hide from immunotherapy. This biomarker is consistent with an efficacious response:
“In addition to the encouraging clinical responses seen thus far, we continue to make progress on identifying immunological biomarkers that correlate with favorable responses,” said William L. Redmond, Ph.D., Associate Member, Laboratory of Cancer Immunotherapy, and Director, Immune Monitoring Laboratory at the Earle A. Chiles Research Institute, a division of Providence Cancer Institute. “We have observed a significant decrease in the frequency of suppressive myeloid-derived suppressor cells (MDSC) following treatment in the responding patients (on day 85 post-treatment).”
Second, numerous pre-clinical studies performed by Galectin Therapeutics and independent academic researchers have demonstrated the effects of Galectin-3 inhibition in the tumor microenvironment. The results of this study in humans is in the context of hundreds of papers that are published each year (exploding in number) in the emerging field of glycobiology.
It seems irresponsible to jump to a conclusion without looking at the whole body of evidence. The top cancer researchers running this trial believe the data is convincing and that is why they are expanding the trial to head & neck cancer patients.
This article is very superficial and non-scientific, just plain wrong.
Very good article.
This article is so biased and incorrect it boggles the imagination.
This study is an Investigator-initiated trial by Portland Providence Cancer Center, one of the leading Cancer Immunotherapy research centers in the United States.
Here is what Dr. Brendan Curti, the lead researcher, said of the results:
MD-02 used in combination with KEYTRUDA and to measure the response rate to combined therapy. “We are very encouraged by the objective response rate and the disease control rate observed in patients with advanced melanoma. These response rates were higher than expected with KEYTRUDA alone,” said Dr. Curti. “An objective response rate of seven out of fourteen patients (50%) and a disease control rate of nine out of fourteen patients (64%) with advanced melanoma is very encouraging. The published objective response rates in randomized studies using KEYTRUDA in patients with advanced melanoma range from 21% in patients who have had prior therapy to 39% in patients who had not received prior systemic therapy. Importantly, the combination was also very well tolerated, and treatment appears to be associated with fewer adverse events than expected with KEYTRUDA alone.”
He also said: Dr. Curti states “the response rates observed overall in advanced melanoma and head and neck cancer patients were better than expected with KEYTRUDA alone and are the basis for moving forward with both tumor types, particularly given the low response rates of anti-PD-1 monotherapy in head and neck cancer. There is a significant clinical need for better options for these patients and our initial objective response rates were encouraging enough to warrant inclusion of additional patients to help determine whether we should also pursue these challenging patient populations in a phase 2 trial. Taken together with the observed favorable safety and tolerability of the combination, these results provide a compelling rationale to move forward with this approach.
The Cohort 3 patients were treated with a higher dose of GR-MD-02 (8 mg/kg) than those in the Cohort 2 trial (4 mg/kg). Based on the findings of Cohort 3 further trials will utilize the 4 mg/kg dose because it appears to be more effective.
Fact is fact, fiction is fiction. This article is pure fiction authored by someone with a motive to bury Galectin Therapeutics; readers should do their own investigation and make up their own minds rather than rely on the fiction presented here
If there was any motive to bury Galectin Therapeutics here, your dissenting view wouldn’t be published directly underneath. You have just cut and pasted text from the company press release. If you want to base your investment decisions purely on company PR, I wish you the best of luck. The rest of us prefer to explore other points of view. The points you missed, or ignored, here are that the cohorts and overall numbers are too small to derive any conclusion that the combination is better than Keytruda alone, and that there is no evidence of a dose response.