The media seems to have woken up from its unconsciousness, overlooking good news in favor of perpetrating negative energy that weighs heavily on people’s psyche. When undeniable cheerful realities emerge, the media can no more ignore it. That’s what we see happening at least in the biotechnology sector these days. Years of overlooking breakthrough approaches that demonstrate promise of improving the prognosis of cancers known to resist conventional treatments have ended and the negative media could not hide its admiration of what it is actually witnessing. Some would find a space to put a “BUT” after praising the drug, but investors have developed expertise in interpreting the but that is put in the wrong place.
They are talking about the experimental breast cancer drug T-DM1 (trastuzumab emtansine) created by ImmunoGen (IMGN) and developed by Roche Holdings AG (ROG). They finally agreed, like we did since a long time, that T-DM1 is phenomenal, no doubt about it. However, the real star of this successful story is not T-DM1, but ImmunoGen’s Targeted Antibody Payload (TAP) technology, which T-DM1 is validating it with the very promising results. The technology is, indeed the breakthrough and is expected to improve the prognosis of many cancers not only HER2 positive breast cancer. In T-DM1 Roche’s Herceptin is used in the antibody conjugate to improve on the drug’s effect and it did. The good news is that the same is being repeated to improve the efficacy of many experimental and approved antibody cancer treatments developed by other firms and by ImmunoGen itself. IT IS BIG.
Trastuzumab emtansine (T-DM1 was presented on Saturday, June 1, in the ASCO meeting. The patients, we remind, had late stage metastatic breast cancers that resist all treatments, including Roche’s Herceptin targeting HER2 receptor on the surface of breast cancer cells. As the antibody reaches its target, then penetrates into the inside of the cancer cells, an extremely potent chemotherapy is detached from the conjugate and unloaded inside the malignant cells, killing them, while sparing healthy cells the toxic effects of the ultra-strong chemotherapy. The results demonstrate the drug has worked and successfully delayed the progression of cancer by 9.6 months, versus 6.4 months for the standard therapy. About 65 percent of patients who got T-DM1 were still alive after two years, compared with 47.5 percent of patients who got Tykerb and chemotherapy.
Imagine what would be the results if and when the drug is given early in the disease. That’s what Roche is embarking on now for T-DM1 and that’s how many ImmunoGen’s antibody drug conjugates will end up being used, i.e., probably as first line therapeutics.
Roche plans to file for approval in the U.S. and Europe by the end of the year and a final review of survival data is due in 2014.
What commentators said?
Finally we were allowed to hear that a professor of medicine at Duke University said in a statement. “The drug worked. --- It was significantly better than a very effective approved therapy.”
We read also that Howard Liang, a Boston-based analyst for Leerink Swann & Co., wrote in a note to investors that the study is “good news for women” because it shows T-DM1 can deliver a potent poison to cancer cells without many of the side effects suffered by the patients who got Tykerb.
A comment made by Jennifer Litton, a breast cancer expert at MD Anderson Cancer Center in Houston, who was not involved in the trial stating, “I have patients calling me asking for this drug.”
Why the technology is very important?
ImmunoGen’s Antibody Payload (TAP) technology is capable of using various antibodies treating diverse cancers. ImmunoGen Chief Executive Officer Dan Junius said “Numerous antibody-drug conjugates like T-DM1 may be available within four years”. Also, Roche is testing the armed antibody technology in eight molecules in early patient trials for prostate, ovarian, breast, non-Hodgkin’s lymphoma and other cancers, A trial combining T-DM1 with Roche breast cancer therapy, pertuzumab, is taking place.
ImmunoGen, indeed, has good news and any “BUT” is not relevant at this time.
The next Prohost Letter is dedicated to cancer. We are following on the news from ASCO. We already have good news from Exelixis (EXEL), Ariad (ARIA) and other small and large cancer drug developers, and we are expecting to hear more good news today from Seattle Genetics (SGEN), Pharmacyclics (PCYC) and others We will report all the important news.
We long ImmunoGen.