Notes from ASCO 2016

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

Reviewing data for cabo and Opdivo in renal cancer

Yesterday at the ECC meeting, BMS (BMY) and Exelixis (EXEL) presented data for their respective drugs ,Opdivo (nivolumab or nivo) and cabozantinib (cabo) in renal cancer (RCC). Before delving into the inevitable comparison, it is important to note that cross-trial comparisons are tricky and it’s impossible to definitively say which drug is better without a direct comparison in the same study.  Nevertheless, the studies were very similar in terms of patient population, control arm and prior treatment lines so as far as cross-trial comparison goes, this is as good as it gets. Continue reading

ECC 2015 – Renal cancer showdown between BMS and Exelixis

The ECC/ESMO meeting, the European equivalent of ASCO, will take place next weekend. Historically, this event has received limited investor attention (since most of the important late stage stuff is reserved for ASCO) but in recent years its importance is growing as more practice-changing data are presented.  As a proof of this trend, this year’s meeting will include the two most important breakthroughs in renal cancer in almost a decade. Continue reading

Exelixis – Renal cancer data are too good to ignore

As followers of this blog know, I have been a long term Exelixis (EXEL) bull for many years but to date the stock has been one of my biggest losers. Despite this experience and although I have been proven wrong on Exelixis in the past, I feel the recent P3 success in renal cancer makes it an attractive story based on (for the first time ever) good visibility on a significant commercial opportunity and a differentiated product profile. Continue reading

ASCO 2015 preview

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

2 prominent themes at ASCO 2014

As expected, the major theme this year was (again) Immuno-oncology with a focus on PD-1 antibodies. Another theme that is gaining momentum is segmentation of tumor types to small niches based on high resolution genomic profiling. This approach can be used to identify a drug’s target population already in phase I, as exemplified by multiple presentations I will discuss below. In most cases, these drugs are ineffective in the general population but highly effective in rare subsets of cancer patients. Continue reading

Drugs to watch at ASCO 2014

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

Immuno-oncology – Key themes for 2014

A lot has been written about the immuno-oncology (cancer immunotherapy) field and how it is expected to revolutionize cancer treatment. In 2013, excitement around immuno-oncology and PD-1 antibodies in particular reached record high levels. In 2014, the trend is expected to continue on several fronts. These include potential approvals, new combination regimens, new indications and new targets.

Below is a review of key catalysts and drivers for immuno- oncology in 2014. Continue reading

Drugs to watch at ASCO 2013

Below is a recap of interesting data expected to be presented at the Annual meeting of The American Society of Clinical Oncology (ASCO).  This year’s meeting will have a strong focus on immunotherapy (PD-1 antibodies in particular) as well as novel oral agents for hematology. Companies for which important data are expected are reviewed as well.

PD-1 takes center stage

PD-1 antibodies are by far the hottest and most active field in cancer drug development. Although technically, all data to date were from phase I studies, there is wall to wall consensus that inhibitors of the PD-1 pathway will become a cornerstone in several cancer types and a $5-$10B franchise.

Continue reading

Major trends in cancer drug development – Notes from TAT 2013

Earlier this month, I attended the TAT (Targeted anticancer therapies) congress in Paris. This conference focuses exclusively on targeted therapies for cancer, one of the most active areas in drug development. As a small conference (~500 participants), it does not generate a lot of high profile clinical data, still, it is a great opportunity to “feel the pulse” of oncology drug development. Speakers include clinical oncologists, basic scientists and industry researchers, which provide a fairly broad spectrum with respect to existing and upcoming trends.

Here, I focus on three major themes from the meeting: PD-1 inhibitors, antibody drug conjugates (ADCs) and cancer metabolism. Continue reading