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Biotech in the spotlight as pharma takes back seat at ASCO

For the past several years, the annual meeting of the American Society of Clinical Oncology has provided a stage for cancer immunotherapy’s rapid rise, documenting major clinical advances made in melanoma, lung cancer and other tumors.

That’s made the conference indispensable for investors in companies like Merck & Co. and Bristol-Myers Squibb, each a leader in immuno-oncology.

This year, however, fewer blockbuster trial results are expected. And both Merck and Bristol-Myers are taking a lower-profile approach, with neither planning to hold investor events for the first time since 2013.

“Those two companies have been the focus of this conference for the last four or five years,” said Brad Loncar, CEO of Loncar Investments and a regular attendee of the event, being held from May 31 to June 4. “They’re both quiet as a mouse this year.”

Cancer research hasn’t slowed down for either drugmaker. For Merck, an R&D event set for later in June made an investor showcase at ASCO unnecessary, while key data for Bristol-Myers’ immunotherapy Opdivo won’t be available in time.

Yet their more subdued presence this year means the spotlight will shine brighter on a number of biotechs scheduled to present data on emerging targeted therapies.

“For the last three to five years, most of ASCO has been dominated by large pharma and it has displaced a lot of the biotechs,” said SVB Leerink analyst Andrew Berens in an interview. “This year the pendulum has swung back.”

Drawing early interest this year are Amgen, Seattle Genetics, Blueprint Medicine, Macrogenics and Puma Biotechnology. Amgen, in particular, will present the first clinical data from its experimental drug AMG 510, which is designed to target mutations in the well-known, but to date intractable, oncogene KRAS.

Doctors, analysts and investors got a first look at what’s to come on Wednesday, when ASCO released abstracts of studies to be presented at the conference. Data contained in trial abstracts are preliminary, but are often poured over for clues.

In Amgen’s case, responses to AMG 510 were evaluated in only 9 patients, with another 13 enrolled but not yet assessed. Two experienced a partial response, while six experienced stable disease. While the numbers might not impress, analysts expect improvement when the full data are presented at ASCO on June 3.

Then, expectations will be high: AMG 510 is a “potentially needle-moving drug for a $100 billion dollar company,” said RBC Capital Markets analyst Kennen Mackay in an interview.

Select studies of interest to be presented at ASCO
Company Drug Cancer type Abstract(s)
Amgen AMG 510 KRAS-mutated solid tumors 3003
Amgen AMG 420 Multiple myeloma 8007
AstraZeneca/Merck Lynparza gBRCAm pancreatic cancer LBA4
Blueprint Medicine BLU 667 RET-mutated lung, thyroid cancers 6018, 9008
Macrogenics margetuximab HER2+ breast cancer 1000
Novartis spartalizumab solid tumors, blood cancers 2507, 6024
Puma neratinib HER2+ breast cancer 1002
Seattle Genetics enfortumab vedotin Bladder cancer LBA4505

SOURCE: ASCO Meeting Library

“While we won’t be seeing as many breakthrough presentations on immunotherapy at this annual meeting, there will be exciting presentations on many fronts,” wrote Gilberto Lopes, an oncologist at the Sylvester Comprehensive Cancer Center at the University of Miami, in an email to BioPharma Dive. Lopes last year presented results from Merck’s widely anticipated KEYNOTE-042 study of Keytruda (pembrolizumab) in lung cancer.

This year, Lopes noted research on the use of targeted agents, such as Roche’s experimental drug entrectinib, in pediatric populations, as well as new studies on unusual molecular changes like translocations in a gene called RET.

A small study of entrectinib in pediatric patients was one of several highlighted by ASCO Wednesday as presentations of note. In the Phase 1 trial of 29 patients, all 12 children and young adults whose tumors harbored changes in the NTRK, ROS1 or ALK genes targeted by entrectinib responded to treatment.

Roche acquired entrectinib in its $1.7 billion deal for Ignyta a year and a half ago.

Targeted therapies like entrectinib have attracted increasing attention, boosted by clinical successes and an improving understanding of the biology behind genetic alterations that drive tumor growth.

Companies are getting better at making these molecules, too, a learning curve on display with Amgen’s KRAS inhibitor.

“KRAS was one of the first oncogenes discovered and there have been a lot of attempts to leverage that as a therapeutic intervention that have failed,” said Leerink’s Berens. “No one felt, prior to these [drugs] that Amgen has and Mirati [Therapeutics] has, that you could actually drug the receptor directly,” he added, referring to a rival drug to AMG 510.

All this makes ASCO a continued draw, even if the immuno-oncology data sets that have highlighted recently past meetings are fewer.

Timing plays a role as well. While previously companies might have held data to present at ASCO, it’s now common for large data sets to get disclosed at smaller conferences like ASCO’s Genitourinary Cancers Symposium, where Merck in February debuted the data behind Keytruda’s recent approval in kidney cancer.

Annual meetings like those for the Society for Immunotherapy of Cancer, the American Association of Cancer Reserach and the European Society of Medical Oncology are frequently news-making as well.

“I think much more is getting released throughout the year,” said Loncar. “The whole ASCO being the Super Bowl is much less true today than before.”