June 22, 2024

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CD47 Gets a Positive Turnaround: Gastric Cancer Drug ORR Reaches 52%

CD47 Gets a Positive Turnaround: Gastric Cancer Drug ORR Reaches 52%, mDOR Exceeds 7.4 Months



 

CD47 Gets a Positive Turnaround: Gastric Cancer Drug ORR Reaches 52%, mDOR Exceeds 7.4 Months.

For most of this year, CD47 has been in a state of decline, with Arch Oncology announcing the abandonment of CD47 antibody development, leading to employee layoffs. Gilead terminated two Phase III clinical trials of its CD47 monoclonal antibody, Magrolimab, due to safety and efficacy concerns. ALX Oncology halted the development of CD47-blocking fusion protein ALX148 for hematologic indications, and AbbVie dropped the CD47-targeting drug, Vuzolitinib, from its partnership with TeneoBio.

As previously reported, amidst the skepticism, defending CD47 was essential. In times of recession, those who hold their ground can see a clearer future. And now, we await the positive data brought by ALX Oncology for gastric cancer.

On October 3rd, ALX Oncology announced preliminary efficacy results from the mid-term data of ALX148 in the Phase II ASPEN-06 clinical study. This marks the first positive randomized clinical trial data for a CD47 inhibitor.

 

CD47 Gets a Positive Turnaround: Gastric Cancer Drug ORR Reaches 52%, mDOR Exceeds 7.4 Months

 

 

ALX148, developed by ALX Oncology, is a SIRPα V1D1-Fc fusion protein and represents the next generation of CD47 blockade therapy. It addresses the common concern of CD47-related hematologic toxicity by modifying ALX148 so that it does not damage red blood cells even when binding to CD47 on their surface.

According to ALX Oncology’s press release, ASPEN-06 is a randomized, double-blind, multicenter, international Phase II clinical trial designed to evaluate the efficacy of ALX148 in combination with Trastuzumab, Ramucirumab, and Paclitaxel in treating HER2-positive gastric/gastroesophageal junction cancer (G/GEJ).

The interim analysis, involving 54 randomized patients with G/GEJ in the second and third lines of treatment, reveals promising preliminary results. The overall objective response rate (ORR) for the group receiving ALX148 in combination with Trastuzumab, Ramucirumab, and Paclitaxel reached 52%, compared to 22% in the control group without ALX148. Furthermore, as of the reporting date, the median duration of response (mDOR) for the ALX148 group has not been reached, while the control group has a mDOR of 7.4 months.

In terms of safety, the therapy demonstrated overall safety and tolerability consistent with previous clinical studies.

It’s worth noting that these mid-term results significantly outperform the efficacy of Trastuzumab and Paclitaxel alone, as seen in the prior RAINBOW study, with an ORR of 28% and mDOR of 4.4 months, already established as the standard of care for second-line G/GEJ treatment.

The exciting aspect of the ASPEN-06 study lies not only in highlighting the value of ALX148 in solid tumor therapy but also in potentially breaking through the limitations faced by late-stage patients after targeted treatments, where treatment options are often limited and challenging.

According to GLOBOCAN, gastric cancer is the fifth most common cancer worldwide and the third leading cause of cancer-related deaths. The American Cancer Society estimates that by 2023, there will be 26,500 new cases diagnosed in the United States. Approximately 17% of gastric cancer patients are HER2-positive, and the 5-year survival rate for diagnosed metastatic gastric cancer patients is only 5.5%.

The positive aspect of the ASPEN-06 study also underscores its potential in combination with other immunotherapies. As ALX Oncology’s Chief Medical Officer states, ALX148 has the potential to serve as a first-line foundational immunotherapy.

ASPEN-06 is the first global randomized study targeting HER2-positive gastric cancer. Considering that Keytruda and Enhertu have already received approvals for this indication, ALX Oncology aims to leverage this momentum to bring ALX148 to the market as soon as possible. According to their statement, the final analysis of the ASPEN-06 study is expected to be reported in the second quarter of 2024, with plans to initiate the Phase III portion of the study by the end of 2024.

Thanks to this news, ALX Oncology’s stock price rose to $7.76 on the same day, marking a 60% increase.

 

CD47 Gets a Positive Turnaround: Gastric Cancer Drug ORR Reaches 52%, mDOR Exceeds 7.4 Months

 

 

CD47 Gets a Positive Turnaround: Gastric Cancer Drug ORR Reaches 52%, mDOR Exceeds 7.4 Months

References:
ALX Oncology Press Release: https://ir.alxoncology.com/node/8901

(source:internet, reference only)


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