On April 28, 2021 Exact Sciences (NASDAQ: EXAS) reported study results published in Mayo Clinic Proceedings showing that Cologuard (mt-sDNA) is the most cost-effective colorectal cancer (CRC) screening option in the Alaska Native population, as compared to colonoscopy and the fecal immunochemical test (FIT), for a wide range of adherence scenarios (Press release, Exact Sciences, APR 28, 2021, View Source [SID1234578644]). According to the model, Cologuard produced the highest number of quality adjusted life years (QALYs) gained and the largest reduction in CRC incidence.1

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Colorectal cancer is the second leading cause of cancer death for men and women in the United States,2 in part because many cancers go undetected until later stages when treatment is less effective.3 Alaska Native (AN) people have among the nation’s highest reported incidence rates for CRC, at 89.0 per 100,000 people compared to 45.7 per 100,000 people for the entire United States. 4

Despite the clear need, screening AN people presents significant challenges, such as lower sensitivity for cancer and pre-cancer with other stool-based tests and obstacles around getting people from their remote homes to healthcare facilities, which requires significant time, expense, and support personnel.5 The Cologuard test provides a path to overcome these barriers by offering patients a CRC screening test that allows them to collect their sample at home.

An earlier study from lead author Diana Redwood, Ph.D. of the Alaska Native Tribal Health Consortium and Alaska Native Epidemiology Center, analyzed the performance of Cologuard, a U.S. Food & Drug Administration (FDA) approved stool DNA test for colorectal cancer, in AN people. The study showed the non-invasive Cologuard test had high sensitivity in detecting colorectal cancer and large pre-cancerous lesions making it a strong candidate for increasing the screening options available for AN people.5

"My earlier research showed that Cologuard is an effective screening test in Alaska Native people," Redwood said. "This study shows Cologuard would also be a cost-effective way to screen this unique and hard to reach population."

Each strategy reduced costs and increased QALYs in comparison with no screening, with Cologuard outperforming FIT and colonoscopy screening in all adherence scenarios. With perfect adherence assumed, all screening modalities examined (colonoscopy, FIT, and mt-sDNA) decreased CRC incidence relative to no screening, with Cologuard decreasing incidence the most.1,5

A Markov model was used to evaluate the effects of the 3 screening tests over 40 years. Outcomes included CRC incidence and mortality, costs, QALYs, and incremental cost-effectiveness ratios (ICERs). The study incorporated updated evidence on screening test performance and adherence and was conducted from December 15, 2016, through November 6, 2019.5

"Cologuard is supported by Exact Sciences’ built-in patient navigation system, which offers round the clock support for patients. Data shows this support increases test completion rates, especially among people, like many Alaska Native people, who haven’t been previously screened," said Paul Limburg, M.D., Chief Medical Officer, Screening at Exact Sciences

With perfect adherence, CRC incidence was reduced by 52% using 10-yearly colonoscopy, 61% using annual FIT, and 66% using triennial mt-sDNA screening. Compared with no screening, perfect adherence to screening added estimates of 0.19 QALYs with mt-sDNA, 0.17 QALYs with FIT, and 0.15 QALYs per person with colonoscopy. Colonoscopy was found to be the most expensive strategy: about $110 million more than mt-sDNA and $127 million more than FIT. With best-case imperfect adherence, which represents the highest estimated adherence rate based on the authors analysis, mt-sDNA resulted in improvement of 0.12 QALYs/person vs. 0.05 QALYs/person by FIT and 0.06 QALYs/person by colonoscopy. Under other adherence scenarios, mt-sDNA either dominated or was cost-effective as compared with FIT and colonoscopy.5

References:

Redwood DG, Dinh TA, Kisiel JB, et al. Cost-effectiveness of multitarget stool DNA testing vs colonoscopy or fecal immunochemical testing for colorectal cancer screening in Alaska Native people. Mayo Clin Proc. 2020; xx(x):1-15. doi:10.1016/j.mayocp.2020.07.035
Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2021. CA Cancer J Clin. 2021;71:7-33. doi:10.3322/caac/21654
Zauber AG, Winawer SJ, O’Brien M, et al. Colonoscopic polypectomy and long-term prevention of colorectal-cancer deaths. N Engl J Med. 2012;366(8):687-696. doi:10.1056/NEJMoa110370
ACS. Colorectal cancer facts and figures 2020-2022. Atlanta: American Cancer Society; 2020.
Redwood DG, Asay ED, Blake ID, et al. Stool DNA testing for screening detection of colorectal neoplasia in Alaska Native people. Mayo Clin Proc. 2016;91(1):61-70. doi:10.1016/j.mayocp.2015.10.008
Media Contact:
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Financial support and conflict of interest disclosure: Dr. John Kisiel serves, and Dr. David Ahlquist served as scientific advisors to and research collaborators with Exact Sciences Corp., distributors of the multi-target stool DNA test (Cologuard). Exact Sciences also provides support for Dr. Kisiel’s lab and research team at Mayo Clinic. Exact Sciences Corp. had no role in the study design, data analyses, or manuscript preparation. Additional Information: Coauthor David A. Ahlquist, MD, died in November 2020.

About Exact Sciences Corp.

On April 28, 2021 seqWell reported the appointment of Dan Calvo as its President and Chief Executive Officer, effective as of April 19th, 2021 (Press release, Research Corporation Tech, APR 28, 2021, View Source [SID1234578643]). Dan brings over 30 years of leadership experience, most recently serving as President and CEO of Gyros Protein Technologies AB from 2013 through its acquisition by Mesa Labs in 2019. Prior to this role, Dan served as President and CEO of Oncimmune (USA) LLC, a leading early cancer detection company from 2009 thru 2013. He also brings strategic insights from earlier CEO roles at Cellomics and Assay Designs, having led both companies through acquisition by Fisher Scientific and Enzo Biochem, respectively.

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With accelerated growth of its core product offerings, seqWell welcomes Dan at a critical inflection point in the company’s commercial strategy. The recent release of seqWell’s first single-cell solution, plexWell Rapid scRNA, for single-cell RNA-seq applications, alongside strategic OEM partnerships, continues to broaden the company’s collaborative opportunities. According to seqWell Founder and Chief Scientific Officer, Joe Mellor, "Dan’s commercial leadership skills are essential and valuable at this stage of seqWell’s growth and development. I look forward to working closely with Dan as we build on our core capabilities to further meet the needs of the genomics market and build upon our strategic partnerships."

"The outlook for our business is exceptional," said Dan Calvo. "I am excited to work with the tremendous team at seqWell to accelerate development and commercialization of critical tools to meet the increasing global demand for workflow improvements in a wide variety of NGS applications."

Chad Souvignier, Vice-President and Investment Lead at RCT, added "seqWell’s progress this past year has been exceptional. The board worked cooperatively with management over this past year to recruit a CEO who could lead the company through its next stage of growth. We are fortunate to have found Dan and confident in his ability to aggressively move the company forward."

On April 28, 2021 Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) reported that the Company will report its financial results for the first quarter ended March 31, 2021 before the US financial markets open on April 30, 2021, rather than on May 3, 2021 as previously announced (Press release, Alexion, APR 28, 2021, View Source [SID1234578642]).

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Given the previously announced agreement to be acquired by AstraZeneca, Alexion will not be hosting a conference call. Earnings materials will be made available publicly on the Investor Relations page of our website at View Source Questions may be directed to the Investor Relations team via e-mail at [email protected] or the contact information below.

AstraZeneca and Alexion Combination

On December 12, 2020, AstraZeneca and Alexion announced that the companies entered into a definitive agreement for AstraZeneca to acquire Alexion, in which Alexion shareholders will receive $60 in cash and 2.1243 AstraZeneca American Depositary Shares (ADSs) for each Alexion share. Based on AstraZeneca’s reference average ADR price of $54.14 at the time of the announcement, this implied total consideration to Alexion shareholders of $39 billion or $175 per share. The acquisition has the potential to advance the shared science-led mission of both companies to leverage complementary approaches to developing life-changing medicines. The proposed combination will broaden Alexion’s footprint, enabling the company to help more patients, pursue innovative science in new areas and expand its therapies in additional geographies. In addition, the transaction delivers significant value for Alexion’s shareholders, who will have an important stake in the combined company’s future results. Subject to receipt of regulatory clearances and the approval by AstraZeneca and Alexion shareholders, the companies expect the acquisition to close in the third quarter of 2021.

[ALXN-E]

Additional Information and Where to Find It

In connection with AstraZeneca’s proposed acquisition of Alexion (the "proposed transaction"), AstraZeneca filed with the U.S. Securities and Exchange Commission ("SEC") a registration statement on Form F-4 which includes a proxy statement of Alexion and a prospectus of AstraZeneca. The registration statement was declared effective by the SEC on April 12, 2021, and mailing of the definitive joint proxy statement/prospectus to the shareholders of Alexion occurred on or about April 12, 2021. Each of Alexion and AstraZeneca may also file other relevant documents with the SEC regarding the proposed transaction. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE DEFINITIVE JOINT PROXY STATEMENT/PROSPECTUS AND ANY OTHER RELEVANT DOCUMENTS THAT MAY BE FILED WITH THE SEC, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO THESE DOCUMENTS, CAREFULLY AND IN THEIR ENTIRETY IF AND WHEN THEY BECOME AVAILABLE BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION. Investors and security holders will be able to obtain free copies of the registration statement and the definitive proxy statement/prospectus and other documents containing important information about Alexion, AstraZeneca and the proposed transaction through the website maintained by the SEC at View Source Copies of the documents filed with the SEC by Alexion will be available free of charge on Alexion’s website at View Source or by contacting Alexion’s Investor Relations Department by email at [email protected]. Copies of the documents filed with the SEC by AstraZeneca will be available free of charge on AstraZeneca’s website at View Source or by contacting AstraZeneca’s Investor Relations department by email at [email protected].

Participants in the Solicitation

Alexion, AstraZeneca, their respective directors and certain of their executive officers and other employees may be deemed to be participants in the solicitation of proxies from Alexion’s shareholders in connection with the proposed transaction. Information about Alexion’s directors and executive officers is available in Alexion’s proxy statement for its 2020 annual meeting of shareholders, which was filed with the SEC on March 26, 2020, Alexion’s Annual Report on Form 10-K/A for the fiscal year ended December 31, 2020, which was filed with the SEC on February 16, 2021, and other documents subsequently filed by Alexion with the SEC. Information about AstraZeneca’s directors and executive officers is available in AstraZeneca’s Form 20-F filed with the SEC on February 16, 2021, and other documents subsequently filed by AstraZeneca with the SEC. Other information regarding the participants in the proxy solicitations and a description of their direct and indirect interests, by security holdings or otherwise, are contained in the definitive joint proxy statement/prospectus filed with the SEC on April 12, 2021 and other relevant materials to be filed with the SEC regarding the proposed transaction when they become available. Free copies of these documents may be obtained as described in the paragraphs above.

No Offer or Solicitation

This communication is not intended to and shall not constitute an offer to buy or sell or the solicitation of an offer to buy or sell any securities, or a solicitation of any vote or approval, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made, except by means of a prospectus meeting the requirements of Section 10 of the U.S. Securities Act of 1933, as amended.

On April 28, 2021 Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, reported that will present data from Part B of the Phase 1 study of ADXS-503 in combination with pembrolizumab at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held virtually, on June 4-8, 2021 (Press release, Advaxis, APR 28, 2021, View Source [SID1234578641]).

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Presentation Details:

Title: A phase 1 study of an off-the-shelf, multi-neoantigen vector (ADXS-503) in subjects with metastatic non-small cell lung cancer (NSCLC) progressing on pembrolizumab as last therapy.
Session Type: Poster Session
Abstract Number: 2616
Date and Time: June 4, 2021, 9:00 AM (EDT)

On April 28, 2021 BeiGene (NASDAQ: BGNE; HKEX: 06160) reported positive results from a planned interim analysis of the Phase 3 ALPINE trial comparing BRUKINSA (zanubrutinib) against ibrutinib in adults with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) (Press release, BeiGene, APR 28, 2021, View Source [SID1234578640]).

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BRUKINSA met the primary endpoint of the trial, demonstrating non-inferiority in objective response rate (ORR) by both investigator and independent review committee (IRC) assessments (p < 0.0001). The trial also demonstrated superior ORR with a statistically significant improvement in ORR for BRUKINSA vs. ibrutinib (p = 0.0006) by investigator assessment, as well as a numerically higher ORR but not statistically significant improvement by IRC (p = 0.0121 compared to the two-sided stringent statistical boundary of p < 0.0099 set for the interim analysis). The interim analysis from this fully-enrolled, ongoing trial is based on 415 of 652 patients followed for a minimum of 12 months.

Data pertaining to progression-free survival (PFS) in the 652 patients, a secondary endpoint of the trial, were immature at the data cutoff for the interim analysis. However, the descriptive summaries of PFS showed an early trend favoring BRUKINSA.

The trial also met a pre-specified secondary endpoint related to safety. Compared to ibrutinib, BRUKINSA demonstrated a statistically significant lower risk of atrial fibrillation or flutter, which is characterized by an irregular heartbeat that can lead to blood clots, stroke, heart failure and other heart-related complications. Overall, the safety profile of BRUKINSA was consistent with the previously seen profile in its clinical development program.

ALPINE is BeiGene’s second Phase 3 head-to-head trial comparing BRUKINSA to ibrutinib.

Jane Huang, M.D., Chief Medical Officer, Hematology of BeiGene said, "The interim results from this head-to-head trial demonstrated that, as a selective inhibitor designed to deliver sustained and continuous inhibition of BTK, BRUKINSA provides CLL patients with improvements in response and reduced rates of atrial fibrillation or flutter compared to ibrutinib. Data from this interim analysis, in addition to BRUKINSA’s comprehensive clinical program, provide important new information to support its benefit-risk profile."

BeiGene plans to consult with global regulatory authorities on next steps and present these data at an upcoming major medical conference. ORR per IRC will be further assessed at the planned final analysis, and patients will be followed for analyses on key secondary endpoints including PFS.

About Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

Chronic lymphocytic leukemia (CLL) is the most common form of leukemia in adults, with a global incidence of approximately 114,000 new cases in 2017.1,2 CLL affects white blood cells or lymphocytes in the bone marrow.1 Proliferation of cancer cells (leukemia) in the marrow result in reduced ability to fight infection and spread into the blood, which affects other parts of the body including the lymph nodes, liver and spleen.1,3 The BTK pathway is a known route that signals malignant B cells and contributes to the onset of CLL.4 Small lymphocytic lymphoma (SLL) is a non-Hodgkin’s lymphoma affecting the B-lymphocytes of the immune system, which shares many similarities to CLL but with cancer cells found mostly in lymph nodes.5

About ALPINE

ALPINE is a randomized, global Phase 3 trial (NCT03734016) comparing BRUKINSA against ibrutinib in previously treated patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

In the trial, a total of 652 patients were randomized into two arms with the first receiving BRUKINSA (160 mg orally twice daily) and the second receiving ibrutinib (420 mg orally once daily) until disease progression or unacceptable toxicity. The primary analysis of objective response rate (ORR), defined by pre-specified non-inferiority of BRUKINSA versus ibrutinib, was assessed by investigator and independent review committee (IRC) using the modified 2008 iwCLL guidelines with modification for treatment-related lymphocytosis for patients with CLL and per Lugano Classification for non-Hodgkin’s lymphoma for patients with SLL. There was hierarchical testing of non-inferiority followed by superiority in ORR as assessed by investigator and IRC. Key secondary endpoints include progression-free survival (PFS), duration of response, overall survival, and incidence of adverse events. The study is ongoing, with pre-specified endpoints of ORR and PFS to be evaluated at the planned final analysis expected in 2022.

About BRUKINSA

BRUKINSA is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. Because new BTK is continuously synthesized, BRUKINSA was specifically designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared to approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease relevant tissues.
BRUKINSA is approved in the following indications and regions:

•For the treatment of mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy (United States, November 2019)*;

•For the treatment of MCL in adult patients who have received at least one prior therapy (China, June 2020)**;

•For the treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) in adult patients who have received at least one prior therapy (China, June 2020)**;

•For the treatment of relapsed or refractory MCL (United Arab Emirates, February 2021); and

•For the treatment of Waldenström’s macroglobulinemia (WM) in adult patients (Canada, March 2021).

To-date, more than 30 marketing authorization applications in multiple indications have been submitted outside of the United States and China, covering the EU and more than 20 other countries.

*This indication was approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

**This indication was approved under conditional approval. Complete approval for this indication may be contingent upon results from ongoing randomized, controlled confirmatory clinical trials.