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Healthy Returns: Drugmakers Release Promising Cancer Drug Data – And AstraZeneca Wins Big

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Good morning! I'm back in New York City after spending the last weekend in Chicago for the American Society of Clinical Oncology annual meeting.

More than 5,000 research abstracts were presented or published at ASCO. They included data on existing drugs, experimental treatments, AI tools and ideas for improving patient care. 

Here are some data highlights and executive commentary from the larger companies I follow: 

AstraZeneca wins big: 

The company's second-best-selling drug, Tagrisso, reduced the risk of disease progression or death by 84% compared to placebo in patients with stage three non-small cell lung cancer caused by mutations in a gene called EGFR, according to new late-stage trial results. The treatment kept the disease under control for a median of over three years – or 39 months – while patients who received a placebo had a median progression-free survival of around five months.

Dave Fredrickson, executive vice president of AstraZeneca's oncology business unit, told me: "We've got patients that are having almost three years more of time before they're hearing news that their disease has progressed, and half of them haven't even heard that news yet, which means that as we continue to follow this study, there's hope that we're going to see long term durable responses that we could start calling cures."

David Spigel, chief scientific officer at the Sarah Cannon Research Institute in Nashville, during a press briefing last week said the data on Tagrisso "will be practice-changing."

AstraZeneca's immunotherapy Imfinzi reduced the risk of death by 27% compared with placebo in patients with limited-stage small cell lung cancer following chemoradiotherapy, according to another late-stage trial. The presentations for the trials on both Tagrisso and Imfinzi received standing ovations at ASCO. 

Meanwhile, AstraZeneca and Daiichi Sankyo's targeted cancer treatment Enhertu reduced the risk of progression or death by 38% compared to chemotherapy in women with a certain kind of metastatic breast cancer (patients with low expression of a protein called HER2.) All patients in the late-stage trial had received prior treatment, with at least one line of endocrine therapy.

TDCowen analyst Steve Scala wrote in a note Thursday that AstraZeneca's "abundance of positive data" at ASCO reinforces the company's $80 billion revenue target by 2030.

Pfizer shows off its bet on cancer:

Pfizer's drug Lorbrena helped patients live longer without seeing their cancer progress, and most people experienced that benefit for over five years, according to data from a late-stage trial. The medicine also cut the risk of the cancer progressing in patients' brains.

Chris Boshoff, Pfizer's chief oncology officer, told me: "In cancer medicine in general, you always want to give the best medicine upfront first. So that's why we believe this data … will lead to [Lorbrena] becoming a standard" first-line treatment in this specific form of lung cancer.

A treatment regimen that included Pfizer's targeted cancer treatment Adcetris reduced the risk of death by 37% compared to chemotherapy alone in patients with a certain type of lymphoma, according to detailed data from a late-stage trial. 

Merck, Moderna impress with additional cancer vaccine data:

Merck and Moderna's closely-watched personalized cancer vaccine in combination with the immunotherapy Keytruda improved survival and showed long-lasting efficacy in a mid-stage study in patients with severe forms of melanoma. The overall survival rate of patients who took the vaccine in combination with Keytruda was 96% after 2½ years. That compares with 90.2% among those who took Keytruda alone.

Marjorie Green, Merck's head of global clinical development of oncology, told me: "As we look at the three-year updates, what's really exciting to me is seeing the durability of that data."

Stephane Bancel, Moderna's CEO, told me that the progress of a phase three trial on the combination as a treatment for late-stage melanoma is "ahead of our plans" so far.

Bristol Myers Squibb's treatment combo shows promise as first-line treatment for liver cancer:

Treatment with the company's immunotherapies Opdivo and Yervoy reduced the risk of death compared with standard treatments (either Lenvima from Merck and Eisai or Nexavar from Bayer) in patients with previously untreated advanced liver cancer, according to late-stage clinical trial data. Median overall survival was 23.7 months for patients who took the combination compared to 20.6 months with either of the other two drugs.

Meanwhile, Bristol Myers Squibb's lung cancer pill Krazati delayed tumor growth by almost two months in a late-stage clinical trial. Patients who received the drug lived a median of 5.5 months before their cancer progressed or they died. That compares to a median of 3.8 months for patients who received chemo.

Johnson & Johnson showcases a more convenient version of Rybrevant:

J&J presented new late-stage trial data on an injectable version of its lung cancer treatment Rybrevant in combination with a drug called lazertinib. The study showed that the injectable form is comparable to the approved version in patients with a certain type of non-small cell lung cancer. (The approved form of the drug is administered via intravenous infusion, which can be lengthy and cumbersome for patients.) The company plans to seek approval for the injectable version of Rybrevant in the U.S. 

Eli Lilly presents revamped oncology pipeline: 

During an event at ASCO, Eli Lilly gave investors a glimpse at both late-stage and early-stage experimental drugs in its oncology pipeline, along with updates on its existing cancer treatments, including Verzenio and Jaypirca. It comes five years after the company announced the acquisition of Loxo Oncology, which kicked off a reorganization of the cancer unit (and involved terminating much of Eli Lilly's pipeline at the time.)

Jake Van Naarden, Loxo@Lilly president, told me that the windfall from Eli Lilly's popular obesity and diabetes drugs is a rising tide that lifts all boats, including the company's oncology business: "The other thing that is certainly not fully appreciated, actually, is that the success that the company is having right now with the incretin portfolio, both for patients but also financially, really puts Lilly I think in a unique position to invest in other things." 

Feel free to send any tips, suggestions, story ideas and data to Annika at annikakim.Constantino@nbcuni.Com. 

Latest in health-care technology

Digital physical therapy tools provide clinical benefits, report finds

Patients with musculoskeletal conditions who like to stay in their pajamas received some welcome news on Wednesday: They can receive meaningful care from the comfort of their homes, according to a new report from the Peterson Health Technology Institute.

PHTI is a nonprofit that conducts independent evaluations of digital health solutions. For its latest report, PHTI reviewed virtual musculoskeletal tools from Hinge Health, Sword Health, Omada Health, DarioHealth, Kaia Health, RecoveryOne, Limber Health and Vori Health. 

Musculoskeletal conditions limit a patient's mobility and can affect the joints, bones and muscles. These disorders are often associated with pain, and they can be treated with medication, surgery or a form of rehabilitation like physical therapy. 

PHTI said around one in three people in the U.S. Have musculoskeletal conditions, and they account for almost 10% of medical spending in the country, according to a release Wednesday. 

The organization set out to evaluate whether existing virtual tools decrease health-care costs or provide meaningful benefits to patients. PHTI found that several of the solutions "offer clinical benefits to patients that are comparable to in-person physical therapy," the release said. 

To assess the tools' clinical and economic performance, PHTI said it reviewed more than 2,000 scientific articles and received input from experts and patients. 

The organization split the solutions into three categories: physical therapist-guided solutions (Sword, Hinge, Omada, Vori and RecoveryOne), app-based exercise therapy with limited participation from physical therapists (Dario, Kaia) and remote therapeutic monitoring solutions, which are designed to supplement in-person care (Limber).

PHTI said it found that the physical therapist-guided solutions improve patients' functionality and pain in a manner that is comparable to in-person physical therapy. This means that patients who use these solutions from home can expect to see similar results to patients who receive their care in person. 

App-based exercise therapy helped improve patients' pain and function, but those tools are not effective enough to replace in-person care, according to the report. Additionally,  PHTI said that while evidence for remote therapeutic monitoring tools was limited, they deliver better clinical results in combination with in-person physical therapy compared to in-person therapy alone. 

Physical therapist-guided solutions also reduce net spending, according to the report. PHTI said remote therapeutic monitoring tools increase net spending, and there was no pricing data available for app-based exercise therapy. 

PHTI said that based on its review, virtual musculoskeletal tools successfully provide "meaningful improvements in pain and function compared with usual care." The virtual tools can also help increase access to care, particularly for patients who are older, live in rural areas or can't easily travel to an in-person clinic, PHTI said. 

You can read the full report from PHTI here.

Feel free to send any tips, suggestions, story ideas and data to Ashley at ashley.Capoot@nbcuni.Com.

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AstraZeneca And Daiichi Sankyo Announce Clinical Milestone In Phase 3 Study Of Datopotamab Deruxtecan Versus Chemotherapy For Lung Cancer

The study evaluated the efficacy and safety of Dato-DXd compared to docetaxel in adult patients with locally advanced or metastatic NSCLC with and without actionable genomic alterations who require systemic therapy following prior treatment.

Results from the global TROPION-Lung01 Phase III trial were announced recently demonstrating that datopotamab deruxtecan (Dato-DXd) significantly improves overall survival compared to chemotherapy in patients with advanced non-squamous non-small cell lung cancer (NSCLC).

The study evaluated the efficacy and safety of Dato-DXd compared to docetaxel in adult patients with locally advanced or metastatic NSCLC with and without actionable genomic alterations who require systemic therapy following prior treatment.

Lung cancer is one of the leading causes of cancer-related deaths worldwide.

NSCLC is the most common type, accounting for 80% of diagnosed lung cancer cases. Chemotherapy has long been the standard treatment for advanced NSCLC, but new advancements in targeted therapies are showing promising results in improving overall survival rates.

Although immunotherapy and targeted therapies have shown improvement in outcomes for patients with advanced NSCLC in the first-line setting, many patients eventually require chemotherapy after experiencing disease progression.

Despite its limited effectiveness and known side effects, chemotherapy has traditionally been the last treatment option available for these patients.

Dato-DXd is a novel antibody-drug conjugate that targets trophoblast cell-surface antigen 2 (TROP2) overexpressed in cancer cells. Of note, TROP2 is a protein broadly expressed in most NSCLC tumors.

By delivering a potent cytotoxic agent, topoisomerase I inhibitor, directly to cancer cells, the drug is designed to effectively kill cancer cells while minimizing damage to healthy cells.

The trial included patients with advanced or metastatic NSCLC who had previously received platinum-based chemotherapy and an immune checkpoint inhibitor.

Patients were randomized to receive either Dato-DXd or a chemotherapy regimen consisting of docetaxel.

The experimental Dato-DXd drug had shown significant improvement in survival rates compared to standard chemotherapy in patients enrolled in the TROPION-Lung01 Phase III trial. Statistical significance, however, was not reached.

Additionally, the drug demonstrated a favorable safety profile, with manageable side effects reported by patients.

If approved by regulatory authorities, Dato-DXd could potentially become a new standard of care for patients with this challenging form of lung cancer.

"The improvement in overall survival seen with Dato-DXd coupled with the previously reported clinically meaningful progression-free survival, more than doubling of overall response and prolonged duration of response compared to docetaxel suggest that this TROP2-directed antibody drug conjugate could potentially become an important new treatment for patients with NSCLC in this advanced setting," Ken Takeshita, M.D., Global Head, R&D, Daiichi Sankyo, said in a press release.

"These data will support our ongoing discussions with regulatory authorities globally to potentially bring Dato-DXd to patients as quickly as possible and mark another step forward in creating new standards of care for patients with cancer."

Further research is needed to confirm the efficacy and safety of Dato-DXd in larger patient populations, but the positive results from the TROPION-Lung01 trial offer a promising outlook for the future of advanced NSCLC treatment.

Dato-DXd is currently being studied in over 20 clinical trials to determine its effectiveness and safety in various types of cancer, such as non-small cell lung cancer, triple-negative breast cancer and hormone receptor-positive, HER2-negative breast cancer.

If approved by the FDA, Dato-DXd would be a second-line therapy in NSCLC and available in intravenous form. No TROP-2- directed ADC therapies are currently approved for the treatment of patients with NSCLC.

The FDA has assigned a target action date of December 20th, 2024.

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