Brings to mind the case of trastuzumab deruxtecan (T-DXd, brand name Enhertu), an extraordinarily successful new antibody drug conjugate made by Daiichi Sankyo. First, a couple of years ago, it blew the doors off the previous standard of care (made by Genentech) in HER2-positive metastatic breast cancer. Then it went on to win an approval in HER-2 positive gastric cancer, then it went on to win an indication in the previously little-known setting of HER-2 positive metastatic non-small cell lung cancer. (This is a rare form.) T-DXd is so incredibly potent that it requires a much smaller amount of the HER-2 protein target expression on the tumor to be effective. In fact, there's now a new category of HER-2 expression called HER-2 low (midway between HER-2 positive and HER-2 negative) thanks to studies of T-DXd. And now there's a lot of work going on to develop more sensitive tests.
Here's the connection with DCVax and prospects for a tumor-agnostic approval. At ASCO 2023, Daiichi unveiled results of a phase 2 basket trial called Destiny PanTumor-02, which assessed the efficacy and safety of T-DXd in a handful of different solid tumors such as bladder, biliary tract, cervical, endometrial, ovarian, and pancreatic. According to a late-breaking ASCO abstract, the overall response rate among about 260 patients to the study drug across all tumor types was about 37% (https://meetings.asco.org/abstracts-presentations/220035).Destiny Pan-Tumor-02 is the first study to take a tumor type agnostic approach for cancer treatment with an antibody-drug conjugate, according to a Japanese physician who was a discussant on the ASCO abstract. (https://dailynews.ascopubs.org/do/destiny-pantumor-02-trastuzumab-deruxtecan-has-activity-against-range-her2-expressing).
My point is this: First, Daiichi won several FDA approvals the old-fashioned way by running several large-scale mostly phase 3 trials specific for each tumor type, one at a time. Slow, painstaking, expensive. Then, after racking up several tissue-specific approvals, Daiichi ran a phase 2 basket trial with half a dozen tumor types in the same trial and got some truly impressive results. No tissue-agnostic FDA approval for T-DXd yet, but it's coming (IMO).
For me, the takeaway is this: a tumor-agnostic approval for DCVax could happen eventually, but it is not going to happen any time soon.
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