Bristol-Myers, Roche will top burgeoning I-O market worth $29B: analyst

Bristol-Myers Squibb may be falling behind in the metastatic cancer race, and Roche is dealing with biosimilar attacks on its top-selling drugs. But the two companies are the front-runners in the arguably bigger market of adjuvant immuno-oncology, according to one financial services house.

For therapies intended to reduce the risk of relapse in patients whose tumors have been surgically removed, the market could reach $29 billion in peak sales across eight key cancer types, making it "the next key battleground," a Credit Suisse team led by analyst Vamil Divan, M.D., said in a note to investors.

Their projected leader in that market could raise some eyebrows. It’s Bristol-Myers, whose star PD-1 inhibitor Opdivo has racked up key failures in lung cancer lately. But Divan’s team figures the U.S. pharma’s peak sales in the adjuvant cancer setting could reach $9.6 billion.

"[BMS] benefits from its unique adjuvant positions in esophageal, gastric and liver cancer. It is also a fast-follower in neoadjuvant lung, muscle-invasive bladder, kidney (RCC) and head & neck cancers," the analysts wrote in a Monday note.

Opdivo has been gradually falling behind Merck & Co.’s rival drug Keytruda, especially in the lucrative lung cancer field. Just a few days ago, BMS announced it had voluntarily pulled its application for an Opdivo-Yervoy combo in a subset of patients with newly diagnosed non-small cell lung cancer. The decision followed the revelation last October that the FDA had asked for more data and pushed back its decision on the pairing. In addition, the combo’s recent phase 3 readouts in small cell lung cancer weren't up to par, throwing uncertainty on its conditional approval in the setting. 

But take NSCLC for example, the Credit Suisse analysts said. Only 25% of patients with the disease have their tumors caught early enough for surgery, but the analysts still believe it’s a $6.5 billion opportunity, "driven by the sheer size of the market and the potential for longer durations of therapy."

And while there’s still much room for I-O growth in the metastatic market for the foreseeable future, in the long run, adjuvant I-O therapy could "cannibalize" the metastatic market. As Divan’s team sees it, expanded use of I-O drugs in the adjuvant setting could lead to a reduction in relapse rates and a shrinking of the metastatic market over time, and patients may not be considered for metastatic I-O if they fail in the adjuvant I-O setting. That means Merck has the most to lose from a shift toward adjuvant therapy, but the company is "well-balanced" with its own projected adjuvant sales of about $6 billion, Divan said. 

Roche came up second on Divan’s scoreboard, with a total potential of $7.0 billion in adjuvant sales, thanks to its lead in triple-negative breast, muscle-invasive bladder and neoadjuvant lung. Partly thanks to that potential, Credit Suisse has upgraded its rating for Roche from "underperform" to "neutral."

The Swiss drugmaker is in a transition phase, as its trio of legacy cancer blockbusters Rituxan, Herceptin and Avastin face biosimilar erosion. Its PD-L1 Tecentriq is no match for Opdivo or Keytruda in terms of total sales, but it’s at least now in the lead in a potential use before surgery for triple-negative breast cancer (TNBC), with data submission expected this year. And with an FDA priority review designation, Tecentriq could also be the first I-O therapy in the tough-to-treat metastatic TNBC population.

Adjuvant treatments could take up a larger share in breast cancer. Unlike lung cancer, the wide use of screening means that most breast cancer patients are diagnosed at an early stage, and that in turn means more eligible patients for neoadjuvant and adjuvant treatments, Divan noted.

AstraZeneca has $4.1 billion in adjuvant sales potential, according to Divan’s calculations. The team noted that Imfinzi already has significant experience in a setting closely related to adjuvant treatment: stage 3 NSCLC. Last September, AZ unveiled data showing Imfinzi could cut the risk of death by 32% compared to standard-of-care treatment regardless of patients' levels of biomarker PD-L1. That trial, Divan noted, is still the only pivotal study so far to evaluate immuno-oncology therapy in an earlier stage of lung cancer.

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