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 Developed by Eli Lilly and Co's <LLY.N> Loxo Oncology and marketed
by German drugmaker Bayer <BAYGn.DE>, it fights a rare genetic
mutation that appears in less than 1% of solid tumors, regardless of
where they appear in the body.
Finding those patients will require widespread adoption of
sophisticated tests that look for multiple genetic alterations that
could be driving the cancer.
So far, progress has been slow.
Adoption of so-called next-generation sequencing (NGS) tests has
been stalled by lack of reimbursement from insurers over concerns
that the evidence is not there yet to support widescale use,
according to more than a dozen interviews with oncologists and
pharmaceutical and diagnostic industry executives.
As a result, pharma companies from small biotech Blueprint Medicines
Corp <BPMC.O> to larger rivals Lilly and Roche Holding AG <ROG.S>
are taking matters into their own hands, bulking up staff to
increase patient and physician awareness about testing and building
up a gene testing infrastructure that for many community hospitals
still does not exist.
Bayer executives told Reuters it plans to spend $70 million to
increase patient and physician awareness of testing for rare
mutations and to encourage regulatory approval of more tests. They
expect that budget to expand as Vitrakvi continues to win approval
in other countries.
Lilly told Reuters the company has signed an agreement with Thermo
Fisher Scientific <TMO.N> to develop a companion diagnostic test for
its experimental drug, LOXO-292.
The deal adds RET mutations - the target of both Lilly's and
Blueprint's drugs - to Thermo's Oncomine Dx Target Test, which local
pathology labs can use to identify multiple genes linked with
non-small cell lung cancer.
The agreement is aimed to help identify more lung and thyroid cancer
patients who may benefit from the Lilly or Blueprint therapies. The
Thermo test is already approved by the U.S. Food and Drug
Administration - a key standard for Medicare coverage, the companies
said.
According to Dr. Brian Alexander, chief medical officer of Roche's
gene testing company Foundation Medicine, only about 15% of U.S.
patients with advanced cancers get comprehensive genomic profiling.
Another 25% get single-gene testing, he said, and a large proportion
"are not getting any testing at all."
At MD Anderson, which sees 100,000 new cancer patients a year, only
around 10,000 eventually have their tumors sequenced.
For a rare few, the tests are lifesaving.
Xin Zheng, 47, a mother of three in Michigan who was referred to
Reuters by Blueprint, was diagnosed with stage 4 lung cancer in
2016. After failing several treatments, she was out of options.
Her husband, Zhigang Wei, asked for genetic sequencing, and the test
turned up a RET mutation. After contacting multiple lung cancer
experts, Zhigang found an early-stage clinical trial treating
patients with Blueprint's experimental drug, BLU-677.
Now, Xin is nearly back to normal.
“My wife is lucky," he said, adding her quality of life is much
better and she has hope for the future.
Finding patients with such rare mutations is like "looking for the
needle in the haystack," said Stefan Oelrich, head of
pharmaceuticals at Bayer.
Dr. David Hyman of Memorial Sloan Kettering Cancer Center, who
tested Vitrakvi in clinical trials, said making these tests the norm
for advanced cancer patients will require a huge shift in the way
oncology is practiced.
"It's painful to know there are patients out there with these
alterations who are dying without knowing about it and without
getting any treatments," he said.
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NOT GETTING TESTED
For Bayer's Vitrakvi and Roche's Rozlytrek, along with similar drugs
in development, genomic testing is critical to finding patients who
can benefit from them.
Cancer patients and drug companies alike got a boost last year when
the federal Medicare health program for the elderly and disabled
said it would cover FDA-approved tests for advanced cancer patients
that can identify hundreds of genetic mutations at once. A Medicare
endorsement is generally followed by widespread coverage decisions
by private insurers.
But the final regulations dropped a requirement that testmakers
prove the tests are cost-effective and improve patient care. That
created an "evidence gap" that has allowed some insurers, also known
as third-party payers, to withhold coverage or demand more proof
that they benefit patients, said Jeff Schreier of Diaceutics PLC <DXRX.L>,
a data analytics company that works with drugmakers to improve
diagnostic testing.
"More payers are coming around, but it's slow," he said.
The most recent coverage policy from CVS Health Corp's <CVS.N> Aetna
approves many single-gene tests for specific cancers, but still
largely considers multi-gene tests experimental. Anthem Inc's <ANTM.N>
policy limits testing to "medically necessary" use and states
there's "insufficient published evidence" to support widespread
testing.
And while Foundation Medicine's and Thermo Fisher's tests are
getting reimbursed from Medicare, many hospitals such as MD
Anderson, which have developed their own tests, are not guaranteed
payment. "Reimbursement is still a driving force," MD Anderson's
Kenna Shaw said of genomic testing, which costs an average of $5,000
per patient globally.
Lilly bought Loxo in January for $8 billion to profit from its
targeted drugs in early-stage development. Bayer secured the rights
to Loxo's two leading compounds in a 2017 alliance.
Dr. Anthony Sireci, Loxo's senior medical director, said the company
has been working to "democratize" testing in the United States by
increasing its use in local pathology labs, where most cancer
testing has traditionally been done. The Thermo Fisher agreement
will support those goals and expand patients' access to
"high-quality genomic testing," he said.
"TEST YOUR CANCER"
Bayer has hired diagnostic experts to help its medical and sales
staff assess the barriers to genomic testing and ensure that local
pathology labs are including the genetic alterations targeted by its
drugs when they profile tumors, the company's oncology strategic
business chief Robert LaCaze said in an interview.
Bayer also launched a public awareness campaign called "Test Your
Cancer" that urges patients to ask their doctors about genomic
cancer testing. The company is working with testing providers to
ensure test reports are easy to understand.
Blueprint, which has six genomically-targeted drugs in development,
told Reuters it plans to hire six diagnostics experts to increase
awareness of the mutations their drugs target, especially in
community medical practices, where 70% of cancers are treated.
Bayer sees signs of progress. Based on internal data, the company
estimates average sequencing rates across tumors neared 30% last
year, and the company saw a two-fold increase in the number of labs
offering tests that carry the mutation targeted by Vitrakvi.
Bayer has not released sales figures for Vitrakvi.
Asked for an update in the most recent earnings call in July,
Bayer's Oelrich said uptake is going "according to plan," but
declined to say how many patients are using the drug. LaCaze said
with very rare cancers like the ones Vitrakvi targets, sales growth
is "something that will build over time."
(Editing by Michele Gershberg and Edward Tobin)
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