Which Pharma Players Dominate The Lung Cancer Space?

Lung and bronchus cancer is the leading cause of cancer deaths in the United States, according to the National Cancer Institute. Lung cancer is of two types, namely non-small cell lung cancer, or NSCLC and small cell lung cancer, or SCLC, with the former more prevalent than the latter. Estimates by the institute also show that a quarter of a million patients are diagnosed with lung cancer in the United States, with 85 percent of them being NSCLC patient.

Lung Cancer Types

Based on the kind of cells found in the cell, NSCLC can be categorized into squamous cell carcinoma, large cell carcinoma and adenocarcinoma. Meanwhile, SCLC is of two types, namely small cell carcinoma or oat cell cancer and combined small cell carcinoma.

Immuno-oncology drugs account for about 30 percent of the total lung cancer drug market in the fourth quarter of 2016, an Investor's Business Daily report, quoting Barclays analyst Geoff Meacham, said.

Merck

Recently, Merck & Co., Inc. MRK got a shot in the arm, as the FDA accepted for review the sBLA for KEYTRUDA, plus chemotherapy, for the first-line treatment of patients, with metastatic or advanced non-squamous, NSCLC regardless of PD-L1 expression and with no EGFR or ALK genomic tumor aberrations. The company had received a May 10 decision date.

In October 2016, the FDA approved Keytruda as a first-line treatment, meaning it could be used in previously untreated lung cancer patients. Keytruda has the distinction of being the only approved first-line treatment for lung cancer. The drug is used to treat metastatic NSCLC patients, with high-levels of PD-L1, a protein that suppresses the immune system. The mode of operation is by blocking the interaction between PD-L1 and another protein called PD-1. Keytruda had already been approved for patients who have gone through chemotherapy for advanced NSCLC. Merck is also supposed to be testing immune-oncology combination, Keytruda, plus Eli Lilly and Co LLY's Alimta.

Bristol-Myers Squibb

Bristol-Myers Squibb Co BMY, with its Opdivo, is the market share leader in the NSCLC space, with Barclays estimating a share of close to 40 percent. In March 2015, the drug was approved for treating patients with metastatic NSCLC, with progression on or after platinum-based chemotherapy.

With Bristol-Myers not being able to make headway, its rivals are slowing and steadily stealing share from it. Last week, the company announced that it would not push for accelerated approval for Opdivo/Yervoy combination in first-line lung cancer. In August 2016, Opdivo failed as a monotherapy for first-line lung cancer, giving Merck the edge, given Keytruda's success as a monotherapy.

Roche

Roche Holding Ltd. (ADR) RHHBY's Tecentriq was approved in October 2016 for treating people with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy. Barclays' fourth-quarter estimates show that Tecentriq is modestly trailing Keytruda and is slowly gleaning share from Bristol-Myers Squibb.

Tecentriq targets PD-L1 protein, unlike Opdivo and Keytruda, which target the PD-1 protein. Its list price is $12,500.

AstraZeneca

AstraZeneca plc (ADR) AZN announced results of a late-stage trial with Tagrisso, a treatment for lung cancer, which showed that the treatment was more effective than chemotherapy in patients with epidermal growth factor receptor T790M mutation-positive advanced NSCLC. These patients were already unsuccessfully treated with an EGFR-targeted tyrokinase inhibitor.

Tagrisso was approved by the U.S. FDA in November 2015 following a priority review. The drug has also been approved in the EU, Japan and other countries and has been accorded fast track review status in China. China offers huge potential for the company, given that it has a huge number of EGFR T790M mutation-positive population.

The company expressed confidence that it can achieve peak annual sales of $3 billion for the drug. A rival drug candidate named rociletinib developed by Clovis Oncology Inc CLVS was shelved in mid-2016 after a FDA panel rejected it.

AstraZeneca is trying to expand Tagrisso's label in earlier lines of the EGFR-mutant NSCLC. The company is evaluating it as a first-line therapy in a Phase 3 trial. Another early stage trial is on to evaluate Tagrisso for treating patients with leptomeningeal disease, a complication of EGFR-mutant NSCLC.

Summing Up...

A FiercePharma report, quoting Bernstein analyst Tim Anderson, estimates Opdivo sales of $8.1 billion in 2021 followed by $6.5 billion for Keytruda, $4.9 billion for Tecentriq and $1.8 billion for AstraZeneca's Tagrisso.

It remains to be seen which company rules the roost in the lung cancer space. Will Bristol-Myers Squibb lose its market leader advantage? Will Merck build on its recent momentum? Will Roche emerge a serious contender in the space? Investors await answers for these questions, as the players in the space fiercely compete against other each other in a bid to gain competitive edge.

Image Credit: By Blausen Medical Communications, Inc. - Donated via OTRS, see ticket for details, CC BY 3.0, via Wikimedia Commons