Although this year’s ASCO contained a limited amount of groundbreaking data, it provided some interesting take-aways and signaled important trends in oncology drug development. Below is my take on a quiet but important meeting.
Immuno-oncology – PD-1 combinations at their infancy
As in previous years, the meeting was dominated by PD-1/PD-L1 antibodies. Now that PD-1 blockers have been tested on every tumor known to mankind (see below a great figure from Merck), focus is shifting to combination regimens with PD-1 as a backbone. Combination partners range from other immune checkpoints to chemotherapy, targeted therapy and radiation. Continue reading →
A new lucrative indication for Sage (and potentially Marinus)
Last week, Sage (SAGE) surprised the market by announcing preliminary but impressive results for SAGE-547 in patients with postpartum depression (PPD, also known as postnatal depression). Four patients with severe PPD experienced a dramatic improvement in their depression score from an average of 26.5 to 1.8. In other words, these patients entered the study with a severe debilitating depression and became symptom-free within 2-3 days. Despite the preliminary nature of the results, they generated a clear efficacy signal that merits evaluating SAGE-547 in a randomized trial, to be started later this year. Continue reading →
As in previous years, the upcoming ASCO meeting will be dominated by immuno-oncology with a particular focus on PD-1 antibodies. The market’s primary focus is expected to be on non-small cell lung cancer (NSCLC) with data from three large randomized trials from BMS (BMY) and Roche. Beyond lung cancer, investors will look for additional indications where PD-1 agents may have clinical utility as monotherapy or in combination with other agents.
Overall, PD-1 programs continue to generate positive data across many indications but to date clinical experience has been sobering. PD-1 antibodies may lead to durable responses in some cases but the vast majority of patients derive limited benefit or don’t respond at all. This is true in most indications with the exception of melanoma where PD-1 antibodies have a dramatic impact and combination with Yervoy appears to lead to further improvement. Below is a recap of some of the data which will be presented over the weekend. Abstract numbers and links are also provided. Continue reading →
Below is my traditional end of the year summary and a recap of catalysts for 2015. As always, I did my best to cover the most important events, let me know if I missed anything… I would like to use this opportunity and wish the readers of this blog a happy and prosperous new year.
Earlier this week at the EORTC meeting, Clovis provided an update on rociletinib (CO-1686) and rucaparib. Not only do the data prove that both drugs are highly efficacious in the relevant patient populations, they also provide key distinguishing factors (safety profile and patient selection) relatively to competing programs. The negative market reaction exemplifies the discrepancy between the progress Clovis is making and its stock behavior. Continue reading →
Below is my ASCO 2014 preview (better late than never…). I tried to make this recap as comprehensive as possible but it is practically impossible to cover all the interesting stuff (let me know if I missed anything dramatic). Unlike last year, I decided to group interesting abstracts based on mechanism of action rather than companies in order to provide a more holistic perspective. On top of attending the conference itself, I will try to attend as many analyst events as possible (this year I have Clovis, Roche, BMS and Incyte on my list) and include them in my post-ASCO write-up. Continue reading →
In 2013, Seattle Genetics’ (SGEN) Adcetris reached market saturation in its approved labeling (relapsed/refractory HL), shifting market attention to label expansion. These include DLBCL, where Adcetris showed impressive efficacy in highly refractory patients (42% response rate, PFS of 5 months) and CTCL (73% response rate). Adcetris is in phase III for earlier stages of HL as well as CTCL, which are viewed as the next opportunity to grow sales. The company will outline its registration strategy for DLBCL in early 2014. Continue reading →
The annual ASH (American society of hematology) meeting will take place next month in New Orleans. Based on the abstracts that were released 2 weeks ago, it seems that after 2 phenomenal years of introducing novel mechanisms, this year’s meeting is going to be more on the evolving landscape in each segment (Btk/PI3K inhibitors, antibody drug conjugates, myelofibrosis, CD38 antibodies, chimeric antigen receptors etc.).
Earlier this week, Genmab (GEN.CO) announced the first J&J (JNJ) – initiated study for daratumumab, an anti-CD38 antibody that already demonstrated phenomenal clinical activity in multiple myeloma. The announcement comes after a drought of more than a year without any new clinical trials or meaningful clinical data. From this point onwards, investors should expect J&J to accelerate daratumumab’s development with a broad and aggressive program, just like it did with ibrutinib. Continue reading →
Last month Array Biopharma (ARRY) announced a licensing deal with Oncothyreon (ONTY) for ARRY-380, a selective HER2 kinase inhibitor for the treatment of HER2+ breast cancer. ARRY-380 is regarded as an insignificant program, evidenced by the modest deal size ($10M upfront) and the lack of market reaction, but this could change once investors make the connection between ARRY-380 and Puma Biotechnology’s (PBYI) neratinib (EGFR/HER2 inhibitor). Although neratinib is more advanced, backed by more clinical data and probably has broader potential, ARRY-380’s selectivity profile could differentiate it in certain clinical settings. As the market is clearly excited with neratinib (Puma has a market cap of ~$1.6B), some of the excitement could eventually be tunneled toward Array as well. Continue reading →