05/22/2019 | Press release | Distributed by Public on 05/22/2019 10:44
Two big pharma titans are battling for supremacy in the field of oncology immunotherapy.
Before poring over the specifics, here's what immunotherapy means: it's a type of cancer treatment that uses the body's immune system to put up a fight against cancer cells.
Merck's Keytruda, or pembrolizumab, and BMY's Opdivo, or nivolumab, are both human, programmed death receptor-1 - PD-1 -inhibitors and belong to a class of biological therapy called immune checkpoint inhibitors.
PD-1 is a checkpoint protein molecule.
The body's immune cells use T-cells, a type of lymphocyte, to regulate the immune response to potential infections and diseases. Cancer cells usually hide under the PD-1 pathway to evade detection by the T-cells and thereby thrive and proliferate.
PD-1 inhibitors such as Keytruda and Opdivo act by blocking the PD-1 pathway, which exposes the cancer cells to the immune system, making them vulnerable to attack.
Source: Merck, Bristol-Myers Squibb
Much of the sales boost for Keytruda is coming from higher usage in first-line non-small cell lung cancer, both as a monotherapy as well as in combination with chemotherapy, Merck said during its first-quarter conference call.
Apart from this, other indications that are contributing in a big way include melanoma, head and neck cancer, bladder cancer and MSI-high cancers, Merck said.
'In the U.S., first-line lung cancer remains a key driver of growth, given further penetration of the chemo combo in both nonsquamous and squamous non-small cell lung cancer.'
Merck had its share of heartaches with the product, with Keytruda failing to succeed in two separate late-stage studies as a monotherapy in already-treated gastric cancer and breast cancer patients.
Source: Merck Q1 conference call transcript
At the end of the first quarter, Merck registered its 1,000th Keytruda study with ClinicalTrials.gov.
The following are upcoming regulatory milestones for Keytruda:
• A PDUFA date of June 10 for first-line treatment of recurrent or metastatic head and neck squamous cell cancer, either as a monotherapy or in combination with chemo.
• A PDUFA date of June 17 for third-line treatment of advanced small cell lung cancer.
Source: Merck Q1 earnings presentation
Merck recently received approval for Keytruda in first-line lung cancer in China, becoming the only PD-1 therapy for the indication in the country. The company sees China as a promising opportunity.
Bristol-Myers Squibb said in its recent earnings call that growth in the Opdivo franchise will be driven by new indications over time, specifically in adjuvant settings. The company said it has a robust program, with readouts in these settings expected in 2020.
Secondly, the company sees an opportunity in the metastatic setting across a range of tumors, including its upcoming readouts in renal and gastric cancers.
The company also expects near-term readouts in NSCLC beginning this summer and into the next year. Incidentally, Opdivo has been approved in second-line and third-line settings in lung cancer.
Bristol-Myers Squibb recently said that its Phase 3 Checkmate-498 study evaluating Opdivo plus radiation versus temozolomide plus radiation in patients with glioblastoma did not meet the primary endpoint.
The Checkmate-714 mid-stage trial that evaluated the Opdivo plus Yervoy combo versus Opdivo in first-line squamous cell carcinoma of head and neck also did not meet its primary endpoint, the company revealed in its first-quarter earnings release.
Earlier in January, the company had to withdraw its regulatory filing for Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) for the first-line treatment of NSCLC patients with tumor mutational burdens of at least 10 mutations/megabase. The company suggested the application may have to be supported with more data.
With Opdivo sales growth slowing and Bristol-Myers Squibb ceding the lead to Merck in the first-line lung cancer setting, it sought inorganic growth with its proposed acquisition of Celgene Corporation (NASDAQ: CELG).
Even with the M&A strategy, the recent Opdivo trial setbacks could make Bristol-Myers Squibb a little uneasy. Its growth rate is trailing behind rival Keytruda. And given Opdivo's significant share of total revenue, weakness in the oncology immunotherapy may have a telling impact on the overall performance of Bristol-Myers Squibb.
On the other hand, Merck's strong Keytruda showing and its diversified portfolio give the company an edge.
Does Bristol-Myers Squibb have a cure for the malaise? The coming days should provide an answer.
Related Link: Merck Is Up 40% In 2018: What's Driving The Rally?
Photo courtesy of Merck.