Hi everyone! Here, we mark another week, and with that there is yet another load of news to consider. So much happens every week that it’s easy to miss the most important stuff. This article is designed to give you a second look and some retrospective on the last week’s news in cancer, as well as how it may have impacted the stocks in question! This comes from my daily series on Seeking Alpha called “3 Things in Biotech You Should Learn Today.”
The Annual Meeting of the European Hematology Association (EHA) is always momentous, providing crucial updates in the world of blood disorders, including cancer. But the fact that it comes right after the complete insanity that is ASCO usually makes it a little bit overlooked. But not in the case of 3 Things!
The big news coming out of the hematologic malignancies was AbbVie’s presentation of venetoclax data in the treatment of multiple myeloma. 8 out of 17 patients achieved a response of some kind, which may improve once data for another 4 patients come in. But it’s the first, very early sign that AbbVie could end up with venetoclax-carfilzomib-dexamethasone as a standard-of-care option in myeloma.
A small company called Aptose also presented findings at EHA. In this case, the focus was on preclinical data for a drug that targets a number of interesting molecules, including BTK (like ibrutinib or acalabrutinib), FLT3 (like midostaurin or gilteritinib), and Trk (like Loxo’s larotrectinib). While they haven’t reached the clinic yet, it’s very interesting to see a drug achieve something with such far-ranging implications!
The biggest news of the day, in my opinion, was Bristol-Myers announcing that they had received approval for nivolumab in the management of non-small cell lung cancer in China. This is the first official approval of a PD-1 inhibitor there, and it was momentous for Bristol. This could be a way forward for them to continue to build market share in the face of competition from Merck. Still, the sentiment for the company remains rather poor in the stock market, as they have not yet recovered the ground lost around the time of AACR. To me, it represents an interesting buying opportunity!
Two pieces of new information came out of EHA on new aspects of relatively older drugs.
It sounds ridiculous to me to say that, though, since Karyopharm’s selinexor hasn’t yet been approved. However, at EHA we saw more evidence of its efficacy, as the STOMP trial provided a glimpse into the potential power of earlier use of selinexor. If Karyopharm is not on your personal watchlist, then you’re missing out on a grand opportunity, without a doubt.
The other big piece of news was that the JAK2 inhibitor ruxolitinib continues to show improvement in patients with myelofibrosis, and in studies that include real-world experience with thousands of patients. This provides important context for the use of ruxolitinib in this disease setting, but it also lets us know how high the bar really is for newcomers to the field.
This day’s edition focused on 3 cancer-related events. The first was that Beigene’s BTK inhibitor is coming along well in its development. Patients demonstrated favorable response rates in the setting of MCL and Waldenstrom’s, making it quite comparable to ibrutinib, which was approved in China only recently. Beigene thus has a major opportunity to claim its own stake in the market share. With all their good news, I’m surprised that Beigene has run out of momentum recently in its stock chart, and I feel as though right now is a good buying opportunity!
Meanwhile, we got a pair of earlier-stage cell therapy updates. Atara Biotherapeutics showed off high response rates for their cell therapy tabelecleucel in EBV-positive lymphoma. And BioLineRx demonstrated a stark ability to mobilize stem cells more rapidly in bone marrow donors. Just one injection of their CXCR4 antagonist was sufficient to get the stem cells they needed from 19 out of 21 patients. That news could very well end up being a quiet game changer for the field of stem cell transplantation, which remains an incredibly important treatment option for blood cancer.
This edition focused on the night-and-day responses coming out of good news for two different companies: Verastem and Geron. Both posted positive results with their drugs, duvelisib and imetelstat, respectively. Verastem showed promise for their PI3K inhibitor duvelisib in CLL, and they shot up from the $5.60 range to stabilize at around $7.50.
Meanwhile, Geron showed an interesting update to their IMerge study in lower-risk MDS, providing tantalizing evidence that imetelstat is providing outstanding benefit for patients without a chromosomal abnormality called del(5q). Patients without this feature remain controversial to manage, with few treatment options and a consequent higher risk of progression to higher-risk MDS or even leukemia, as well as a higher risk of thrombosis.
The news did nothing to regain the momentum Geron saw earlier in the year, and now the slow drip for them continues, possibility until we hear about the continuation decision with Janssen.
The big news for June 20 was the announced findings from EHA on the ELOQUENT-3 study, which is Bristol-Myers’s attempt to move their SLAMF7 antibody into earlier treatment lines for multiple myeloma. Adding the drug to pomalidomide-dexamethasone was shown to be feasible, with significant improvement in both response rates and overall survival.
This is pretty big news for Bristol-Myers, because they’ve seemed to have lost a lot of ground to Janssen with their CD38 antibody daratumumab. And for sure, this announcement isn’t quite as momentous as the what we saw from daratumumab in the ALCYONE study, which moved daratumumab to first-line therapy for certain patients. However, if Bristol-Myers hopes to catch up in this area, it’s going to be through these relatively smaller moves. ELOQUENT-3 is definitely a step in the right direction!
June 21 featured a pair of immune checkpoint disruptors. One is a me-too…Regeneron’s cemiplimab is now being studied in combination with an oncolytic virus called pexastimogene devacirepvec for patients with kidney cancer. There’s not much to say there just yet, other than I am excited and frustrated at the same time with respect to a 6th PD-1/PD-L1 inhibitor coming to market very soon. It sucks a lot of the air out of the room, in the name of yet another big pharma getting its own PD-1 inhibitor. At the same time, it accelerates development of these revolutionary agents, and we might possibly even start to see some price competition, which would be excellent.
We also got an update from Immutep on their anti-LAG-3 biologic eftilagimod alpha. They announced that they’ve reached the midpoint of enrollment for an important phase 2 trial in metastatic breast cancer. There’s not much to say about that here, other than there is an exciting possibility of a large data update to come out of a meeting like SABCS in December. This could end up being a major catalyst for Immutep, and one well worth watching!
3 Things In Biotech, June 22: Cynata A Go In GVHD? Heron Flies In Pain Management; Blueprint Gets Voyaging
There was not much that was enormously important in the cancer world on June 22. Cynata’s report of phase 1 data in GVHD looked promising, but it’s important to keep in mind that phase 1 will almost never be the basis for approval. So we wait!
The more exciting news came from Blueprint Medicines Corporation, who launched the VOYAGER study for avapritinib in a tumor type called GIST. Importantly, this is most certainly going to be the registrational trial for avapritinib, which was granted Breakthrough Therapy designation for the management of GIST. It’s difficult to say how long the trial will take to yield results, but the fact that the FDA has already stamped the drug with Breakthrough means that accelerated approval is definitely on the table is they can show encouraging interim data. Perhaps even something like improved response rates!
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